Identifiers
- 510(k) Number
- K141555 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 ADVANTAGE is a high energy pulsed diode laser system for temporary hair reduction. It is the first laser system to integrate adjustable pulse width control with a large spot chilled compression tip.
The device is supplied by Lutronic Corporation and is authorized under FDA 510(k) clearance with product code GEX. It is designed for use in general and plastic surgery settings, offering a cost-effective choice for dependable hair reduction treatment.
Frequently asked questions
What is the ADVANTAGE laser system used for?
The ADVANTAGE is a high-energy pulsed diode laser system designed for temporary hair reduction. It is intended for use in general and plastic surgery settings.
How is the ADVANTAGE device supplied?
The device is supplied by Lutronic Corporation. It is authorized under FDA 510(k) clearance with product code GEX.
What distinguishes the ADVANTAGE laser system?
The ADVANTAGE is the first laser system to integrate adjustable pulse width control with a large spot chilled compression tip.
What is the regulatory status of the ADVANTAGE?
The ADVANTAGE is authorized under FDA 510(k) clearance. The submission was reviewed as substantially equivalent and filed with 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: PDF Lutronic Corporation ADVANTAGE - Food and Drug Administration, PDF ADVANTAGE_BR_4100604000_US_v3 - cdn.komachine.com, N/A Operator's Manual Advantage Operator's Manual… - FDA.report, ADVANTAGE by Lutronic - Komachine Supplier Profile and Product List
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141555 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lutronic Corporation
Sources (1)
- FDA 510(k) K141555 24 fields · synced Oct 1, 2026