Identifiers
- 510(k) Number
- K951562 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-Max Holmium Laser is a laser device that emits light at a wavelength of 2.1 microns (near infrared) and is capable of a maximum output of 80 watts of power. It features a DoublePulse operating mode that allows delivery of more energy to hard substances with less risk of damaging surrounding soft tissues.
The device is supplied with laser fibers, surgical needles, and handpieces compatible with conventional SMA 905 connectors and proprietary Trimedyne connectors. It received FDA 510(k) clearance (K951562) on July 21, 1995, as substantially equivalent to a predicate device, and is classified under product code GEX. The device is intended for use in general and plastic surgery settings as indicated by the advisory committee review.
Frequently asked questions
What is the OmniPulse-Max Holmium Laser used for?
The OmniPulse-Max Holmium Laser is intended for use in general and plastic surgery settings, as indicated by the advisory committee review, where it delivers laser energy at 2.1 microns wavelength for tissue interaction in surgical procedures.
What power output and wavelength does the OmniPulse-Max Holmium Laser provide?
The device emits light at a wavelength of 2.1 microns (near infrared) and is capable of a maximum output of 80 watts of power, enabling precise energy delivery for surgical applications.
How does the DoublePulse mode work in the OmniPulse-Max Holmium Laser?
The DoublePulse operating mode allows delivery of more energy to hard substances with less risk of damaging surrounding soft tissues by optimizing pulse structure for efficient tissue interaction while reducing thermal spread.
What accessories are supplied with the OmniPulse-Max Holmium Laser?
The device is supplied with laser fibers, surgical needles, and handpieces that are compatible with conventional SMA 905 connectors and proprietary Trimedyne connectors, ensuring flexibility in surgical setup and instrument integration.
What regulatory clearance does the OmniPulse-Max Holmium Laser have?
The OmniPulse-Max Holmium Laser received FDA 510(k) clearance (K951562) on July 21, 1995, as substantially equivalent to a predicate device, and is classified under product code GEX for general and plastic surgery use.
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, Products | Trimedyne, OmniPulse MAX - Trimedyne, Inc | Laser - GoPhotonics, PDF OmniPulse-MAXTMHolmium Laser
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951562 | Class II | Active |
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Manufacturer
- Manufacturer
- Trimedyne, Inc.
Sources (1)
- FDA 510(k) K951562 24 fields · synced Oct 1, 2026