Diode Laser Hair Removal System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162659 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 designed for the removal of unwanted hair using diode laser technology. It operates by emitting laser energy that targets hair follicles to inhibit future hair growth.
This system is supplied as a reusable device intended for use in clinical or professional settings such as dermatology or plastic surgery facilities. It has received FDA 510(k) clearance (K162659) and is classified under product code GEX, with authorization based on substantial equivalence to a legally marketed device.
Frequently asked questions
What is the Diode Laser Hair Removal System used for?
The system is designed for the removal of unwanted hair by emitting laser energy that targets hair follicles to inhibit future hair growth, intended for use in clinical or professional settings such as dermatology or plastic surgery facilities.
Is the Diode Laser Hair Removal System reusable or single-use?
The system is supplied as a reusable device, meaning it is intended for multiple uses after proper cleaning and maintenance between treatments in clinical environments.
How was the Diode Laser Hair Removal System authorized for market release?
The device received FDA 510(k) clearance under submission number K162659, based on a determination of substantial equivalence to a legally marketed predicate device, and is classified under product code GEX.
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: Diode Laser, Ice Ipl, Picosecond Laser - Huamei, Shandong Huamei Technology Co., Ltd, Diode Laser Hair Removal Machine Manufacturer, Pico Laser Tattoo ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162659 | Class II | Active |
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Manufacturer
- Manufacturer
- Shandong Huamei Technology Co., Ltd.
Sources (1)
- FDA 510(k) K162659 24 fields · synced Sep 24, 2026