Identifiers
- 510(k) Number
- K192569 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 Diode Laser Therapy System is a medical device designed for laser-based aesthetic procedures. It utilizes diode laser technology to perform treatments such as hair removal.
This device is authorized under FDA 510(k) clearance number K192569. It is manufactured by San HE Lefis Electronics Co., Ltd. and is intended for use in professional clinical settings.
Frequently asked questions
What is the primary clinical application for the Diode Laser Therapy System?
This device is designed for laser-based aesthetic procedures, specifically indicated for hair removal treatments in professional clinical environments.
Is this device authorized for medical use?
Yes, the Diode Laser Therapy System is authorized under FDA 510(k) clearance number K192569, which indicates it has been found substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of this laser system?
The system is manufactured by San HE Lefis Electronics Co., Ltd., located in the Yanjiao Development Zone, Sanhe County, China.
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: Laser Machine Manufacturer & Supplier | Lefis, Sanhe LEFIS Electronics Co.,Ltd., Sanhe Lefis Electronics Co., Ltd., Sanhe LEFIS Electronics Co.,Ltd. , Diode Laser
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192569 | Class II | Active |
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Manufacturer
- Manufacturer
- San HE Lefis Electronics Co., Ltd.
Sources (1)
- FDA 510(k) K192569 24 fields · synced Sep 26, 2026