Identifiers
- 510(k) Number
- K202980 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)
The Laser Therapy Device is a Laser Therapy Device (Product Code: GEX) designed for non-invasive aesthetic and medical applications. It delivers controlled laser energy to target specific tissues, facilitating procedures such as hair removal, tattoo reduction, skin rejuvenation, and minor cosmetic corrections through photothermal effects.
This device is intended for professional use in clinical or aesthetic settings and has received FDA 510(k) clearance under the Traditional review pathway, classified as Substantially Equivalent (SESE) within the General, Plastic Surgery advisory committee. It is not specified as single-use or reusable, nor is MRI safety or sterility status detailed in the regulatory submission. The device is supplied as a standalone medical instrument, with no explicit storage or handling instructions provided in the data.
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: Leaflife Technology: Manufacturers of Medical & Aesthetic Laser ..., About Us - 深圳市利孚医疗技术有限公司 - leaflife.cn, Shenzhen Leaflife Technology Co., Ltd. - Made-in-China.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202980 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Leaflife Technology Co., Ltd.
Sources (1)
- FDA 510(k) K202980 24 fields · synced Sep 19, 2026