# K962632: Omnipulse/Omnipulse-Max

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Jan 16, 1997 after 195 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Tissue Technologies, Inc. TRU-PULSE™ Pulsed CO₂ Surgical Laser System: named in the summary without a submission number
- (no number) Coherent® UltraPulse® 5000C Aesthetic Laser System: named in the summary without a submission number
- (no number) Trimedyne Optilase® 1000-100 Nd:YAG Laser: named in the summary without a submission number
- (no number) Omni™ Switchtip System: named in the summary without a submission number
- (no number) Tapertip™ Multiuse Holmium Arthroscopy Handpieces: named in the summary without a submission number

## Indications for use
The laser systems are intended for use in multispecialty applications, including dermatology and plastic surgery, discectomy, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology. The fiber optic delivery systems are intended for use with any holmium laser (with a compatible connector) for its cleared applications.

Source page: https://510kreport.com/device/K962632
Methodology: https://510kreport.com/methodology