Identifiers
- 510(k) Number
- K251100 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 IPGTFL-02 is a Laser Surgical Instrument For Use in General and Plastic Surgery and in Dermatology. It is classified as a Class 2 device under product code GEX.
The device received FDA 510(k) clearance K251100 through the Traditional pathway on September 19, 2025, after a 162-day review. It is manufactured by Ipg Medical Corporation and is substantially equivalent to a 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: K251100 FDA 510 (k) - IPGTFL-02 | Ipg Medical Corporation, IPGTFL-02 (K251100) — FDA 510(k) | Innolitics, IPGTFL-02 510 (k) K251100 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251100 | Class II | Active |
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Manufacturer
- Manufacturer
- IPG Medical Corporation
Sources (1)
- FDA 510(k) K251100 24 fields · synced Sep 26, 2026