Diode Laser Hair Removal System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141973 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A diode laser hair removal system is a device intended for hair removal using laser energy at a wavelength of 808nm. It is designed for stationary, commercial application and is supplied as a desktop unit.
The system is manufactured by Beijing Anchorfree Technology Co., Ltd. and has received FDA 510(k) clearance under K-number K141973 with product code GEX. It has a net weight of 18kg and dimensions of 510mm x 330mm. The device is authorized for sale and distribution as specified in its regulatory submission.
Frequently asked questions
What is the diode laser hair removal system intended for?
The device is intended for hair removal using laser energy at a wavelength of 808nm, designed for stationary, commercial application in settings such as clinics or salons.
How is the diode laser hair removal system supplied and what are its physical characteristics?
The system is supplied as a desktop unit with a net weight of 18kg and dimensions of 510mm x 330mm, making it suitable for fixed placement in commercial environments.
What regulatory clearance does the diode laser hair removal system have?
The device has received FDA 510(k) clearance under K-number K141973 with product code GEX, indicating it was found substantially equivalent to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: L808MED_AnchorFree, DepiLight_AnchorFree, Beijing Anchorfree Technology Co.,Ltd. Diode Laser FHR Hair Removal ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141973 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Anchorfree Technology Co., Ltd.
Sources (1)
- FDA 510(k) K141973 24 fields · synced Sep 21, 2026