Identifiers
- 510(k) Number
- K962632 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 Omnipulse/Omnipulse-Max is a laser system. It is substantially equivalent to predicate devices, including the Tissue Technologies, Inc. TRU-PULSE Pulsed CO₂ Surgical Laser System, Coherent UltraPulse 5000C Aesthetic Laser System, and the Trimedyne Optilase 1 Nd:YAG Laser.
The Omnipulse/Omnipulse-Max is supplied by Trimedyne, Inc. and has been cleared under FDA 510K, with the reference number K962632. The device is classified under product code GEX.
Frequently asked questions
What is the Omnipulse/Omnipulse-Max laser system used for?
The Omnipulse/Omnipulse-Max is a laser system that is substantially equivalent to predicate devices including the Tissue Technologies, Inc. TRU-PULSE Pulsed CO₂ Surgical Laser System, Coherent UltraPulse 5000C Aesthetic Laser System, and the Trimedyne Optilase 1 Nd:YAG Laser.
What is the regulatory status of the Omnipulse/Omnipulse-Max laser system?
The Omnipulse/Omnipulse-Max laser system has been cleared under FDA 510K with the reference number K962632. It is classified under product code GEX and is supplied by Trimedyne, Inc.
What advisory committee reviewed the Omnipulse/Omnipulse-Max laser system?
The Omnipulse/Omnipulse-Max laser system was reviewed by the General, Plastic Surgery advisory committee, with the review advisory committee designated as SU.
When was the Omnipulse/Omnipulse-Max laser system cleared by the FDA?
The Omnipulse/Omnipulse-Max laser system received FDA clearance on January 16, 1997, with the application being received on July 5, 1996.
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: OMNIPULSE/OMNIPULSE-MAX (K962632) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962632 | Class II | Active |
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Manufacturer
- Manufacturer
- Trimedyne, Inc.
Sources (1)
- FDA 510(k) K962632 24 fields · synced Sep 26, 2026