Model 1210 OmniPulse Holmium Laser System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K915117 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 Model 1210 OmniPulse Holmium Laser System is a medical laser device that utilizes Holmium:YAG technology for surgical applications. It is designed to deliver energy to hard substances while minimizing damage to surrounding soft tissues.
This system is supplied by Trimedyne, Inc. and is authorized under FDA 510K clearance with product code GEX. It is intended for use in general and plastic surgery procedures, with various laser fibers, surgical needles, and handpieces available for different applications.
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: Home | Trimedyne, Trimedyne® 1210 OmniPulse™ Holmium Laser System, TRIMEDYNE, INC. 1210-VHP Trimedyne® 1210-VHP OmniPulse Max™ Holmium ..., Products | Trimedyne, TRIMEDYNE, INC. 1210-VHP Trimedyne® 1210-VHP OmniPulse Max™ Holmium ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K915117 | Class II | Active |
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Manufacturer
- Manufacturer
- Trimedyne, Inc.
Sources (1)
- FDA 510(k) K915117 24 fields · synced Sep 24, 2026