Red Light Therapy Product Quotes and Landed Costs: A Complete Buyer's Guide

Last updated: September 17, 2026 | Estimated reading time: 14 minutes

Red light therapy product quotes and landed costs can be difficult to compare because a factory price rarely includes every expense required to receive, clear, and use the goods in the destination market.

Quick answer: A complete landed-cost calculation should include the product price under the agreed Incoterm, export packaging, international freight, cargo insurance where applicable, customs duty, import VAT or GST, brokerage, destination charges, and last-mile delivery. It should also separate one-time OEM/ODM development costs from recurring per-unit costs.

The gap between a quoted factory price and the final landed cost can be larger than the headline quote suggests because freight, import duties, market-specific compliance work, and packaging may be quoted separately or omitted. A compact wearable usually has a lower chargeable freight weight, while a large panel order may add volumetric or dimensional weight charges, pallet fees, and broker or terminal handling on arrival.

This guide explains every layer of the cost structure — from LED sourcing and thermal management to MOQ, OEM/ODM fees, freight, customs, and compliance documentation — so brand owners, distributors, wholesalers, clinics, and other B2B buyers can compare red light therapy manufacturer quotes on the same basis.

What shapes the price of a red light therapy product?

Cost components of a red light therapy device from LED chips to landed cost

Red light therapy device pricing reflects real engineering decisions — it is not arbitrary. Every line on a factory quote traces back to a specific component or process choice. Before comparing supplier prices, it helps to understand what you are actually comparing.

The cost drivers stack in this order:

1. LED chip grade — wavelength bin sorting influences how consistently a panel delivers output around specified wavelengths such as 660 nm red or 850 nm near-infrared. Tighter bin tolerances can increase component cost, but long-term irradiance stability also depends on drive current, junction temperature, optics, assembly quality, and operating conditions.
2. Power electronics — driver efficiency, thermally rated components, and protection circuitry all affect bill-of-materials cost.
3. Thermal management — heat sinks, fan arrays, passive cooling structures, and thermal interface materials may be used according to the design. They influence junction temperature, output stability, component life, and electrical safety.
4. Housing material — cold-rolled steel versus aluminum versus plastic changes both unit cost and product durability.
5. Compliance overhead — market access may involve FDA establishment registration and device listing in the United States, applicable CE conformity assessment and an EU Declaration of Conformity in the European Union, FCC equipment authorization where applicable, RoHS documentation, third-party product safety evaluation, and ISO 13485 quality-system audits. These are different regulatory or conformity-assessment activities, not interchangeable product certifications, and their cost depends on the product, market, and pathway.

Then comes the concept most buyers underestimate: landed cost. The FOB factory price is where the quote starts, not where your cost ends. International freight, destination-country import duties, VAT or GST at the border, customs brokerage, and last-mile warehouse delivery can collectively add a meaningful percentage to that initial figure — and that stack applies whether you order ten units or ten thousand.

Wavelength accuracy and irradiance stability at the specified measurement distance are engineering outcomes that can affect bill-of-materials cost. Delivering a high, stable irradiance at 6 inches may require an appropriate combination of LED quantity and binning, drive current, optics, power electronics, and thermal design. A figure measured at 6 inches should not be compared directly with one measured at a shorter distance or with a different detector, warm-up period, grid, or test geometry.

Our own R&D experience illustrates this concretely. According to REDDOT LED's internal product-improvement record, when the R&D team proposed upgrading the RD-1500 on September 21, 2022, the existing design used 150 red-light LEDs and 150 near-infrared LEDs. In red-only or NIR-only mode, only half the light sources were active, widening the spacing between active emitters. Because near-infrared output is not reliably assessed by visual inspection and may appear dim or invisible to the human eye, some users could incorrectly assume that part of the device was not operating. The proposed fix — dual-chip, four-pin LEDs integrating one red chip and one NIR chip each, driven by two independent power outputs with separate dimming controls — improved emitter distribution but required new PCB design, power-supply development, and sample validation. LED costs were expected to increase. That design decision shows how a mid-cycle component upgrade can affect sourcing, scheduling, validation, and ultimately the per-unit price buyers see in quotes.

Understanding these layers is the starting point for evaluating any red light therapy product quote with confidence.

How quotes are built: from factory price to landed cost

Flowchart from factory FOB quote through freight customs and local fees to final landed cost

When buyers compare red light therapy product quotes and landed costs, the factory price is only the first input. Every step between the factory floor and your receiving dock adds a real, calculable charge. Understanding the full sequence lets you request complete cost breakdowns rather than accepting headline FOB numbers.

Here is the sequence in order:

1. EXW or FOB factory price — the baseline quote. Under EXW, the buyer takes on most transport and export responsibilities from the named place, although local law may affect who can complete export clearance. Under FOB, which is intended for sea or inland-waterway transport, the seller clears the goods for export and delivers them on board the buyer's nominated vessel at the named port of shipment. The exact named place or port and the Incoterms® 2020 rule should appear on the quote.
2. Export packaging and documentation — commercial invoice, packing list, certificate of origin, and any product-specific compliance documents.
3. International freight — sea freight is slower but substantially cheaper per unit on bulk panel orders; air freight trades cost for speed and is typically reserved for samples, urgent restocks, or high-value compact devices.
4. Destination-country import duty — tariff classification depends on the product's objective characteristics, function, intended use, destination-country rules, and supporting documentation. Origin, trade agreements, and trade-remedy measures may also affect the final duty. A broker or customs authority should confirm the code instead of relying only on a supplier's marketing description.
5. VAT or GST at the border — import VAT or GST may apply in the EU, UK, Australia, Canada, and other markets. Recoverability, deferral, and the taxable base depend on local rules and the importer's status, so the amount should be treated as both a tax and a cash-flow consideration until confirmed locally.
6. Customs brokerage and port or terminal handling — fees can include entry preparation, document processing, inspection, storage, terminal handling, and delivery-order charges. A bonded warehouse is used only when the shipment and customs procedure require it.
7. Last-mile delivery to your warehouse or fulfillment center.

Basic landed-cost formula:

Landed cost = product value under the agreed Incoterm + export and international logistics + cargo insurance where applicable + customs duty + import VAT or GST + brokerage and destination charges + last-mile delivery

For a per-unit figure, divide the shipment-level landed cost by the number of saleable units received, not simply the number originally ordered. This accounts for samples, replacements, damaged units, and other non-saleable inventory when relevant.

Compliance documents are not cosmetic items in this chain, but the required documents differ by market and product classification. In the United States, relevant records may include FDA establishment registration and device listing, an applicable premarket pathway or exemption, and FCC equipment authorization where required. In the European Union, the manufacturer must identify the applicable legislation, complete the required conformity assessment, prepare technical documentation, and issue an EU Declaration of Conformity before affixing CE marking. ISO 13485 is a quality-management-system standard rather than a product approval. Missing, inconsistent, expired, or inapplicable documentation can lead to regulatory inquiries, inspections, marketplace restrictions, or shipment delays, with responsibility allocated according to the contract and the parties' legal roles.

The MOQ factor works quietly in the background. High minimum order quantities spread tooling amortization and compliance overhead across more units, compressing per-unit cost. Low-MOQ and sample orders carry proportionally higher overhead per piece, which is why new brands testing the market often see quotes that look steep until they understand what the fixed costs are covering.

On wavelength mix: adding 850 nm or a dual-wavelength 660/850 nm configuration can change LED sourcing, driver architecture, optical layout, testing, and inventory requirements. The price difference depends on actual component quotes and production volume; wavelength alone does not prove that one configuration is more expensive or offers better therapeutic value. For infrared light therapy product quotes, compare the intended application, verified optical output, wavelength tolerance, controllability, and total system cost.

A production-side example makes the BOM dynamics tangible. According to REDDOT LED's internal engineering-change record, in April 2022 the Production and Sales teams proposed an optimization for the RD-6000 after reviewing the current capacity of its original IEC power inlet when multiple units were connected. The change — a dedicated power inlet, a metal push-button switch, and a master/slave switching function — required revised housing drawings, component resourcing, and subsequent electrical validation. The housing drawing revision was planned for May 4, 2022 and completed on May 5, one day behind schedule. This example shows how a production engineering change can alter component sourcing, validation, and pricing timelines. Any public version of the case should be supported by the approved engineering-change record and final verification results.

Knowing the full cost sequence before you request quotes puts you in a position to compare suppliers on total cost, not just factory price.

Typical price ranges: personal devices, mid-tier panels, and professional systems

Side-by-side cost comparison of personal mid-tier and professional red light therapy devices

There is no universal wholesale price range for red light therapy products. Current factory pricing changes with model, wavelength configuration, order quantity, customization, compliance scope, accessories, warranty, packaging, destination, and Incoterm. The useful comparison is therefore a like-for-like quote by device tier:

Ask suppliers to state the unit price, quantity break, included accessories, customization scope, tooling or NRE, packaging, lead time, warranty, named Incoterm, and quote-validity period. Without these fields, two apparent price ranges may describe different products and responsibilities.

Entry-level personal devices

Compact handheld and wearable units — intranasal devices, therapy flashlights, and localized-use belts — often have lower component counts and more modest power requirements than full-size panels. REDDOT LED's RT-1 Rhinitis Lamp product record, for example, lists 12 × 3 W LEDs at 650 nm, irradiance of 10 mW/cm², an 8 × 2 cm dimension, and a system weight of 0.78 kg. The published specification should identify the irradiance measurement distance and whether the stated dimension refers to the emitter, applicator, or complete assembly. The practical challenge at this tier is that some compliance expenses are establishment-, product-family-, project-, or market-level costs rather than simple functions of device size. FDA registration, EU conformity assessment, EMC or electrical-safety testing, and RoHS documentation therefore should be quoted separately according to the applicable pathway and scope. At low MOQ, genuinely fixed project costs can represent a larger fraction of per-unit cost than they do on a bulk panel order.

Portable multi-wavelength spot devices at this tier serve e-commerce buyers and home users seeking localized wellness applications. They illuminate a smaller area than full-size panels and should be compared according to intended use, measured output, illuminated area, instructions for use, and market authorization rather than being presented as direct substitutes for full-body systems.

Mid-tier home and studio panels

Medium-power panels — roughly in the 100–300 W range — introduce steel or aluminum housing, fan cooling, and dual-wavelength LED arrays. These features push cost above the entry tier for concrete reasons: steel housing requires more tooling, fan assemblies add components, and sourcing matched-bin 660/850 nm LEDs at consistent quality adds procurement overhead.

Irradiance claims deserve particular scrutiny here. Two panels marketed at the same input wattage can deliver different irradiance distributions at 6 or 12 inches depending on LED quantity and binning, drive current, optical design, panel area, thermal conditions, and measurement method. Input wattage is an electrical measurement and should not be treated as optical irradiance. Request calibrated, traceable irradiance and spectral data at stated distances, including average, peak, uniformity, warm-up time, operating mode, detector details, and grid method. Independent testing can strengthen confidence, but a competent in-house laboratory using controlled and documented methods can also provide useful production data.

Professional and OEM/ODM systems

At the professional tier, the RDPRO1500-FS8 Ultra Slim illustrates what the cost can cover: SPCC cold-rolled steel housing, cooling components, touchscreen control, optional remote and mobile-app integration, independently adjustable wavelength channels, an NIR pulse range specified at 0–9999 Hz, 11 preset application modes, a manufacturer-rated 50,000-hour LED lifespan, and a three-year warranty. Its eight-wavelength configuration includes 590, 630, 660, 670, 810, 830, 850, and 1060 nm. Model-specific documentation may include FDA establishment registration and device listing records, CE-related documentation, FCC equipment authorization where applicable, and RoHS evidence; none of these should be presented as FDA product approval. For sports recovery centers, physiotherapy facilities, and medical aesthetic practices, total cost of ownership includes acquisition price, documented duty cycle, preventive maintenance, downtime, warranty scope, parts availability, and verified output stability. A lower per-session cost can be claimed only after those variables and actual utilization are calculated.

OEM/ODM customization adds a separate cost layer that first-time buyers frequently overlook. Adjusting logo, wavelength mix, control system, or packaging introduces non-recurring engineering (NRE) charges — tooling fees, firmware development, certification re-testing — that appear as line items in quotes and do not amortize until sufficient volume is reached. Understanding NRE costs upfront prevents budget surprises when the formal quote arrives.

Salon vs. home use: understanding the real financial gap

Professional salon treatment room versus home bedside red light therapy setup

The question of how much red light therapy costs depends almost entirely on which model of use you are evaluating. Per-session clinic costs include device amortization, staff time, facility overhead, consumables, and business margin — a structure that looks expensive compared to a factory quote until you account for what the clinic is actually providing.

Consider a realistic commercial scenario. A sports recovery center investing in a professional full-body panel for continuous daily use across multiple clients is amortizing a meaningful capital cost over hundreds of sessions per month. If the device maintains stable irradiance and operates without downtime, the per-session cost drops steadily over its working life. If the device overheats under continuous use, requires frequent servicing, or fails within the first year, the per-session economics collapse — and that is before accounting for the reputational cost of canceling client appointments.

This is where thermal design and warranty terms stop being technical details and become financial variables. A panel with documented thermal validation, an appropriate cooling design, and a three-year warranty gives the recovery-center operator inputs for a total-cost model. A lower-priced panel is not automatically less reliable, but inadequate heat dissipation, limited parts support, or unclear warranty exclusions can increase the true cost per session once downtime and repair rates are factored in.

The financial gap between salon and home use is clearest when comparing equipment capacity and operating model. Some professional panels are designed to illuminate a larger area or support higher commercial utilization, but the words "professional" and "clinic-grade" do not by themselves prove higher irradiance, better uniformity, or a medical indication. For large-area wellness, sports-recovery, or professional-use applications, compare measured irradiance maps, illuminated area, rated duty cycle, mounting system, instructions for use, and applicable regulatory status.

Where the gap may narrow is in localized, frequent home use. For applications identified in the device's lawful labeling and instructions for use, a compact personal device may have a low amortized hardware cost when used over 12 to 24 months. The calculation should include purchase price, expected service life, accessories, maintenance, replacement parts, electricity, and actual use frequency. Buyers should match the device tier to intended application and illuminated area rather than defaulting to either extreme.

The right question is not "salon or home?" but "what is the intended application, and which device tier supports it at a sustainable per-session cost while following the product's lawful labeling and instructions for use?"

Where quotes go wrong: hidden costs and quality signals buyers miss

Buyer reviewing supplier quote with compliance gaps and red flags highlighted

An FDA establishment registration number is not FDA approval, clearance, or authorization of a facility or its devices. FDA also states that it does not issue device registration certificates. Buyers should separately verify the establishment record, device listing, product classification, and any applicable 510(k), De Novo, PMA, enforcement discretion, or exemption status. A registration record and a product test report serve different purposes; attaching a test report does not turn registration into FDA approval. Confusing these documents can create problems during regulatory review, import screening, or a platform compliance audit.

Incomplete compliance packages follow a predictable pattern. For an EU product, the Declaration of Conformity should identify the product, responsible manufacturer, applicable legislation, conformity-assessment route, and standards or specifications used. The supporting technical documentation and test evidence must match that scope; EMC, LVD, MDR, RoHS, or other requirements apply only when the product falls within their respective scope. An ISO 13485 certificate should be checked against the certified legal entity, site, activities, scope, certification body, and validity period; it is a quality-management-system certificate, not a product approval. Documentation gaps can lead to regulatory inquiries, marketplace restrictions, retesting, or shipment delays, and the responsible party depends on the contract and applicable law.

Three specification areas that require careful verification in supplier quotes are irradiance, wavelength consistency, and thermal performance. Irradiance results depend on measurement distance, detector type, calibration, angle, aperture, warm-up time, operating mode, grid, and whether the reported value is a peak or an average. Buyers should request calibrated data at clearly stated measurement planes — for example, 6 inches and 12 inches when relevant to the intended setup — rather than comparing an undefined peak reading with a mapped average. A nominal 660 nm claim should be supported by spectral data showing the measured peak wavelength, bandwidth, tolerance, and test conditions.

On legitimate cost: a significantly lower red light therapy product quote should trigger a like-for-like review rather than an immediate assumption of either superior efficiency or inferior quality. LED sourcing, thermal engineering, applicable EMC and electrical-safety testing, photobiological safety assessment under IEC 62471, ISO 13485 quality-management-system audits, packaging, warranty reserves, and ongoing production controls all carry real overhead. IEC 62471 addresses photobiological safety; it is not an EMC standard. The applicable EMC standard depends on the product's classification, intended use, circuitry, and target market. Ask the supplier to explain measurable differences in BOM, scope, test evidence, warranty, Incoterm, and included services.

Our own production work makes the safety-cost relationship concrete. According to REDDOT LED's internal corrective-action record, during assembly of RDPRO products the Production team found that enclosure screws did not always provide repeatable electrical continuity between the upper and lower metal covers. The existing protective-earth conductor connected to the lower cover, while the coating could reduce continuity through the screw path to the upper cover. The team treated this as a protective-bonding issue requiring risk assessment and verification; any relationship to electromagnetic emissions or display stability should be stated only if supported by test data. Two corrective options were proposed: add a dedicated bonding conductor between covers, estimated at approximately RMB 0.50 per unit, or reroute an existing power-input protective-earth conductor to the upper-cover aluminum substrate at no additional component cost. The proposal, accepted on November 21, 2022, also called for SOP revision, operator retraining, and verification. This example shows why documented risk management, engineering change control, protective-earth continuity testing, and final validation are financially relevant to quote integrity. Any public version should remain consistent with the approved corrective-action and verification records.

The MOQ issue runs in the same direction, but low MOQ alone is not evidence of grey-market components or missing safety testing. It may reflect standard-product inventory, flexible manufacturing, a market-entry strategy, or limited customization. The relevant warning sign is a quote that combines unusually low pricing with unclear component traceability, missing model-specific compliance evidence, unsupported performance claims, or no written warranty. The possible landed cost of corrective action, a recall, a platform restriction, or a customs hold is not shown in the initial quote, so buyers should assess those risks separately.

Practical guidance for requesting and evaluating quotes

Checklist for evaluating red light therapy product quotes and landed costs

A credible quote package is more than a price per unit. What separates a useful supplier response from a number on a spreadsheet is the documentation that surrounds it.

When you request a quote, these items should come back with it — or be available on request without hesitation:

• LED chip grade or BOM disclosure — at minimum, the supplier should confirm wavelength-bin controls and whether the LEDs meet the product's stated peak-wavelength and tolerance specifications; 660 nm and 850 nm are common configurations, but the required range depends on the product specification
• Irradiance and spectral data at defined measurement planes — a single peak figure at 6 inches tells you less than mapped measurements at 6, 12, and 24 inches when those distances are relevant; request the meter, calibration status, warm-up time, grid, average, peak, uniformity, operating mode, and wavelength data
• Market- and model-specific compliance documents — verify the correct record type rather than looking for one universal registration number: FDA establishment registration and device listing plus any applicable premarket record or exemption; EU Declaration of Conformity and supporting technical evidence; FCC SDoC or FCC ID as applicable; RoHS evidence; and an ETL listing or report where claimed
• Warranty terms and after-sales commitment in writing — vague promises are not terms
• Price basis stated explicitly — state the named place or port and the Incoterms® 2020 rule, such as EXW, FOB, or CIF; each allocates costs and risk differently, and FOB or CIF should be used only for sea or inland-waterway transport

To receive a more accurate red light therapy product quote, send the supplier a structured request containing:

• company name, website, sales channel, and destination market
• product model, intended application, wavelength configuration, and required controls
• expected sample quantity, first order, and annual forecast
• standard product, private label, OEM, or ODM scope
• logo, housing, firmware, packaging, manual, and accessory requirements
• required compliance pathway and the party responsible for local registration or market access
• preferred delivery date, destination address or port, and requested Incoterm
• warranty, spare-parts, inspection, and after-sales expectations

Once you have a clearly defined price basis, build your own landed cost model. A practical structure is: product value under the selected Incoterm + main freight + cargo insurance where applicable + destination charges + customs duty + import VAT or GST + brokerage + inspection or storage charges + last-mile delivery. Do not assume that all red light therapy products fall under HS heading 9018 or 8543. Ask a qualified customs broker or the destination-country customs authority to classify the specific product based on its objective characteristics, function, intended use, documentation, and origin. Running the calculation with the same assumptions makes quotes from different suppliers more comparable.

On the question of the cheapest way to enter red light therapy, start with a product whose intended use, labeling, model-specific compliance documentation, optical data, warranty, and target-market pathway can be verified — not simply the lowest-priced listing. Products with incomplete documentation can create customs, regulatory, or platform risks that should be included in the purchasing decision. For localized home wellness applications, REDDOT LED offers a compact wearable belt with 105 LEDs, 18 W rated input, and a listed weight under 1.1 kg. For a fixed-location application within its labeled intended use, the RT-1 is listed at 0.78 kg. These examples are not universal recommendations; buyers should compare illuminated area, measured output, instructions for use, market status, and total landed cost. Mid-panel buyers should evaluate calibrated irradiance data and distribution together with electrical input wattage rather than treating wattage as optical performance.

The table below shows how the same FOB price can land very differently depending on shipping method and market:

The takeaway: sea freight often has a lower per-unit transport cost for suitable bulk orders, while air freight may be justified for samples, urgent restocks, or compact high-value devices. The decision should use current door-to-door quotes and include chargeable weight, origin and destination charges, insurance, expected clearance time, and last-mile delivery.

A supplier's willingness to provide complete technical and compliance documentation — without being asked twice — is itself a quality signal. Buyers who have mapped their use case, session frequency, and target market before requesting infrared light therapy product quotes are in a far stronger position to evaluate what they receive.

Key Takeaways

• A factory price is not the same as the total landed cost.
• Compare the same model, configuration, quantity, accessories, warranty, packaging, and Incoterm.
• Separate one-time tooling and NRE charges from recurring per-unit costs.
• Confirm the optical test method, measurement distance, average, peak, and uniformity instead of comparing wattage alone.
• Verify market- and model-specific documents; FDA registration, CE documentation, FCC authorization, RoHS evidence, ETL listing, and ISO 13485 certification are not interchangeable.
• Confirm tariff classification, customs value, origin, duties, import taxes, brokerage, destination charges, and last-mile delivery with qualified local professionals.
• A lower quote may reflect different scope, volume, automation, service, or commercial strategy; price alone does not prove either efficiency or reduced quality.

FAQ

How much should I charge for red light therapy?

There is no universal or industry-mandated session price. Start with the annualized landed equipment cost, financing, maintenance, consumables, staff time, facility overhead, taxes, expected paid sessions, and target margin. Then compare the result with lawful local pricing and demand.

Break-even cost per session = total annual operating and equipment cost ÷ realistic annual paid sessions

Use realistic utilization rather than maximum theoretical capacity. This is a business-pricing calculation, not a recommendation for treatment frequency or duration.

Why are red light therapy products so expensive?

The price reflects more than LED count. A properly specified red light therapy device may include wavelength-bin controls, stable power electronics, thermal management, optical and electrical testing, production controls, packaging, warranty reserves, and market-specific conformity assessment.

REDDOT LED maintains FDA establishment registration and model-specific documentation for applicable CE, FCC, RoHS, ETL, and other market requirements, while its medical-device quality system is certified to ISO 13485:2016 within the certificate's stated scope. These records serve different purposes and do not collectively mean that every model is FDA approved or automatically authorized in every market. Buyers should compare the exact model, legal manufacturer, certificate or report scope, validity, intended use, and destination-market requirements.

What is the cheapest way to get red light therapy?

For some buyers, a verified compact device with the required market documentation has the lowest total entry cost. The lowest purchase price is not necessarily the lowest landed cost after freight, taxes, accessories, maintenance, warranty coverage, and actual use frequency are included.

Do not use cost per mW/cm² as a stand-alone value metric: irradiance at one point is not total optical power, uniformity, radiant exposure, safety, or evidence of a particular outcome. Compare calibrated irradiance maps, spectral data, illuminated area, instructions for use, warranty, and landed cost. Buying directly from a manufacturer may reduce distribution margins, but the actual difference depends on order volume, service scope, logistics, taxes, and channel agreements.

What is the best affordable red light therapy tool?

The best affordable option is the lowest-total-cost device that fits the intended application and has verifiable optical, safety, warranty, and market-access documentation. A compact desktop panel may be practical for localized home wellness use, but its actual coverage must be confirmed at the specified use distance.

Prioritize calibrated irradiance distribution and spectral data at the stated measurement plane rather than peak wattage. A 660/850 nm configuration may offer selectable red and near-infrared output, but different wavelengths have different absorption and scattering characteristics rather than fixed, guaranteed penetration depths. A dual-wavelength device is not automatically more effective or better value than a single-wavelength device; the comparison should follow the device specification, lawful labeling, optical test data, safety assessment, and intended use.

References

• U.S. Food and Drug Administration. Are There "FDA Registered" or "FDA Certified" Medical Devices? FDA explains that establishment registration and device listing do not denote approval, clearance, or authorization.
• Electronic Code of Federal Regulations. 21 CFR 807.39 — Misbranding by reference to establishment registration or registration number.
• European Commission. CE marking for manufacturers. The manufacturer is responsible for the applicable conformity assessment, technical documentation, EU Declaration of Conformity, and CE marking.
• UK Medicines and Healthcare products Regulatory Agency. Regulating medical devices in the UK. Great Britain and Northern Ireland have different medical-device requirements, and current CE transitional arrangements are model- and route-dependent.
• Electronic Code of Federal Regulations. 47 CFR Part 2, Subpart J — Equipment Authorization Procedures. FCC equipment may follow Supplier's Declaration of Conformity or Certification, depending on the equipment and applicable rules.
• International Organization for Standardization. ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes.
• International Electrotechnical Commission. IEC 62471:2006 — Photobiological safety of lamps and lamp systems.
• International Trade Administration, U.S. Department of Commerce. Know Your Incoterms. Incoterms® 2020 allocates specified delivery, cost, and risk responsibilities; FOB and CIF are sea and inland-waterway rules.
• European Union. Council Directive 2006/112/EC on the common system of value added tax, especially Articles 85–86 on the taxable amount for imports.
• Intertek. "ETL Listed and IEC Safety Certification for Electrical Products." Verify the listing, report, model scope, production site, and current status through the issuer's official directory or documentation.
• Health Canada. "Medical Device Licence No. 113779 — Therapy Light Family (RDPRO1000, RDPRO1500, RDPRO300, RDPRO750)." Verify the current licence holder, device family, class, and status in Health Canada's official Medical Devices Active Licence Listing database.