A test report, a management system certificate, and a market authorization are three different documents, and red light therapy device sellers routinely present one as if it were another. Keeping them separate prevents most certification misunderstandings.
- Test report – an accredited laboratory measured a specific sample on a specific date against a specific standard.
- Management system certificate – a certification body audited a quality system at a named address, for a named scope.
- Market authorization – a regulator or notified body assessed a defined device with defined intended use and allowed it to be placed on the market.
None of the three is transferable by default. That single sentence prevents more expensive mistakes than any other in this article.
United States: clearance belongs to its holder
Photobiomodulation devices marketed with medical claims are generally regulated as Class II devices requiring premarket notification, and the FDA published draft guidance on 510(k) submissions for these devices in January 2023. Check the agency’s public 510(k) database for the number, the holder, the device trade name, and the indications for use.
A contract manufacturer may appear as a manufacturing site on someone else’s clearance, but that does not allow you to sell your own brand under it. If the intended use on the clearance does not match your label, you do not have coverage. Establishment registration and device listing are separate obligations again.
Devices sold without medical claims may fall under the general wellness policy instead, which is a legitimate route but constrains what you can say in marketing. Be cautious with any red light therapy device supplier who describes a device as “FDA approved”; the agency clears devices through premarket review and does not approve them in the way the phrase implies. That wording alone is a signal about how carefully the rest of the file has been assembled.
European Union: you become the legal manufacturer
Under Regulation (Евросоюз) 2017/745, a whole-body therapy bed with therapeutic claims will usually be classified as Class IIa, although classification follows intended purpose rather than product category, so confirm it rather than assume it. A Class IIa device normally requires a notified body, which means a certificate carrying a four-digit notified body number that can be checked against the NANDO database.
Read the certificate scope line by line. It must cover the device family you are buying and the manufacturing site that actually builds it. A certificate issued for a handheld LED beauty appliance does not extend to a full-body bed.
More importantly, a factory certificate does not transfer to you. When you place the device on the market under your own name, you become the legal manufacturer and you need your own technical documentation, an EU authorized representative, unique device identification, post-market surveillance, and a vigilance procedure. Buying an OEM red light therapy device reduces engineering effort. It does not reduce regulatory responsibility.
Electrical, ЭМС, and photobiological safety
The technical core of the file is a set of safety standards, and each one answers a different question. МЭК 60601-1 covers general electrical safety for medical electrical equipment. МЭК 60601-1-2 covers electromagnetic compatibility. МЭК 60601-1-11 applies where the device is intended for the home healthcare environment, which matters for consumer beds. МЭК 62471 covers the photobiological safety of lamps and lamp systems, and is the standard that speaks directly to eye and skin exposure. Laser-based designs bring IEC 60825-1 into scope. ИСО 14971 underpins the risk management file that ties all of it together.
For each report, confirm the model designation, the sample identification, the test date, and the accreditation of the laboratory to ISO/IEC 17025. Then ask what has changed since the report was issued. A new driver, a denser array, or a revised heatsink alters both the thermal profile and the emissions profile, and the original report no longer describes the product in the box.
Depending on your market, add RoHS and REACH compliance for the European Union and FCC Part 15 verification for the control electronics in the United States. These are supporting documents rather than the main event, but a red light therapy device supplier who cannot produce them has not exported much.
