# Trimedyne, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 60 (1981–2005): 58 510(k) clearances and 2 original PMA approvals
- Product codes: GEX (48), LNK (3), LYK (2), LPC (1), GGX (1), LLO (1), FKR (1), FDA (1), LDR (1), LWX (1)
- Predicates its devices cite: 15 (11 its own); citations of its devices by later devices: 24 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Surgical Laser Technologies, Inc.: 1 (https://510kreport.com/company/surgical-laser-technologies)
- Indigo Medical, Inc.: 1 (https://510kreport.com/company/indigo-medical)

## Firms that cite its devices most
- Clarus Medical, LLC: 2 (https://510kreport.com/company/clarus-medical)
- Richard Wolf Medical Instruments Corp.: 2 (https://510kreport.com/company/richard-wolf-medical-instruments)
- Wontech Co., Ltd.: 1 (https://510kreport.com/company/wontech)
- Asclepion Laser Technologies GmbH: 1 (https://510kreport.com/company/asclepion-laser-technologies)
- New Star Lasers, Inc.: 1 (https://510kreport.com/company/new-star-lasers)
- Fibertech GmbH: 1 (https://510kreport.com/company/fibertech)
- Dornier Medtech America, Inc.: 1 (https://510kreport.com/company/dornier-medtech-america)
- Quanta System Spa: 1 (https://510kreport.com/company/quanta-system)

## Its most-cited devices
- K973172: Resposable Bare Fibers (1998), cited by 4
- K954597: Right Angle Laser Fibers (1996), cited by 3
- K002308: Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model 1210-VHP and 1500-a (2000), cited by 3
- K932883: Optilase Model 1000-100 ND: Yag Laser System (1994), cited by 2
- K992230: Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP (1999), cited by 2
- K915223: Metal Enclosed Side Firing Fibers (1992), cited by 1

## Recent decisions
- K053457: Vapormax II (Dec 21, 2005)
- K050412: Vapormax (Mar 14, 2005)
- K043012: Omnipulse Mini, Model 2120 (Nov 17, 2004)
- K041660: Trimedyne Holmium Laser Systems (Sep 8, 2004)
- K022655: Trimedyne Side Firing Needle with Vent Sheath (Nov 7, 2002)
- K013974: Rmnipulse Holmium Laser System/1210; Max/1210-VHP; JR. 1230-30; N/a 1500-a (Sep 23, 2002)
- K002308: Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model 1210-VHP and 1500-a (Dec 20, 2000)
- K001676: Omnipulse Holmium Laser System, Omnipulse-Max Holmium Laser System, Model 1210, 1210-VHP, 1500-a (Nov 2, 2000)

Source page: https://510kreport.com/company/trimedyne