Key Certificates for Cosmetic Lasers Worldwide

(Cosmetic lasers for hair removal, rejuvenation, tattoo removal, etc.)Cosmetic lasers are classified as medical devices or Class II devices (moderate risk). Certificates confirm safety, effectiveness, and quality. Here are the main ones worldwide as of 2026:

1. USA: FDA Clearance (510(k))
   Mandatory for sale in the United States.
   Lasers receive "clearance" as Class II devices for "permanent hair reduction" (not "removal").
   The FDA checks safety and effectiveness by comparing to predicate devices.
   Examples: Candela GentleMax, Cynosure, Tria Laser — all have FDA clearance.
   Without it — import and sales are prohibited.
2. Europe (EU and EEA): CE Marking
   Mandatory under the MDR (Medical Device Regulation 2017/745).
   Most cosmetic lasers fall into Class IIa or IIb.
   Requires technical documentation, clinical data, and audit by a Notified Body (e.g., BSI, TÜV).
   CE marking allows free circulation and sales in 27+ EU countries.
   For purely non-medical/cosmetic devices — sometimes GPSD applies, but usually MDR is required.
3. Russia and EAEU: Roszdravnadzor Registration Certificate (RU)
   Mandatory for Russia, Kazakhstan, Belarus, etc.
   Lasers are classified as medical devices and require RU registration (similar to full approval).
   Plus EAEU Declaration/Certificate of Conformity (TR CU).
   Without RU — fines and sales ban.
4. China: NMPA (formerly CFDA) Registration
   Required for the local Chinese market.
   Many manufacturers (Weifang KM, Nubway, etc.) hold it.
5. Other countries

• Canada: Health Canada Medical Device License
• Australia: TGA (Therapeutic Goods Administration) — ARTG listing
• Brazil: ANVISA registration
• South Korea: KFDA/MFDS approval
• Japan: PMDA approval
  6. International quality standards (voluntary but build trust)
• ISO 13485: Quality Management System for medical devices
• IEC 60825-1: Safety of laser products (international standard)
• ANSI Z136: Laser safety standard (mainly for the USA)

Recommendations before purchasing
Always check:

• FDA 510(k) database (fda.gov)
• EUDAMED database (for CE marking)
• Roszdravnadzor registry (for RU)

For import into Russia — RU from Roszdravnadzor is mandatory; CE and/or FDA are big advantages.
Many Chinese lasers have CE and ISO, but verify authenticity — there are many fakes. If a device lacks key certificates — risks include fines, seizure, and no warranty/support.If you need details on a specific model — feel free to ask! Romshi — manufacturer of 808 nm diode stacks
Supplier of devices and spare parts
www.romshi.com
+79180110234
Shipping from China
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