Trimedyne, Inc.

Medical device manufacturer in Irvine, CA.

58510(k) clearances
2PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K053457Vapormax IIGEX · Traditional 12/21/2005SE
K050412VapormaxGEX · Traditional 03/14/2005SE
K043012Omnipulse Mini, Model 2120GEX · Traditional 11/17/2004SE
K041660Trimedyne Holmium Laser SystemsGEX · Traditional 09/08/2004SE
K022655Trimedyne Side Firing Needle with Vent SheathGEX · Traditional 11/07/2002SE
K013974Rmnipulse Holmium Laser SYSTEM/1210; MAX/1210-VHP; Jr. 1230-30; N/A 1500-AGEX · Traditional 09/23/2002SE
K002308Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model…GEX · Traditional 12/20/2000SE
K001676Omnipulse Holmium Laser System, Omnipulse-Max Holmium Laser System, Model 1210…GEX · Traditional 11/02/2000SE
K992574Omnipulse Holmium Laser System Model 1210, Omnipulse-Max Holmium Laser System Models…GEX · Traditional 10/29/1999SE
K992230Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HPGEX · Traditional 07/12/1999SE
K973172Resposable Bare FibersGEX · Traditional 02/03/1998SE
K970422Right Angle Laser Fibers;Optilase Nd:Yag Laser;Optilase PL100 ND Laser SystemsGEX · Traditional 04/21/1997SE
K964585Resposable Omni Tip(Tm) Switchable Tips (Multiple)GEX · Traditional 04/17/1997SE
K962632Omnipulse/Omnipulse-MaxGEX · Traditional 01/16/1997SE
K954597Right Angle Laser FibersGEX · Traditional 03/11/1996SE
K953494Tapertip Multisue Holmium Arthroscopic Handpiece, Various Endfiring Models, With/Out a…GEX · Traditional 09/14/1995SE
K951562Omnipulse-Max Holmium LaserGEX · Traditional 07/21/1995SE
K944204Lateralase, ModifiedGEX · Traditional 11/28/1994SE
K941419Disposable Spinal Introducer SheathGEX · Traditional 06/21/1994SE
K932883Optilase Model 1000-100 ND: Yag Laser SystemGEX · Traditional 06/21/1994SE
K934865Omnipulse Model 1210-VHP Ho:Yag Laser SystemGEX · Traditional 05/12/1994SE
K925414Lateralase CatheterGEX · Traditional 03/01/1994SE
K925124Trimedyne Model 1210 Omnipulse Holmium Lase SystGEX · Traditional 03/01/1994SE
K922497Optilase Nd:Yag Models 1000/4000 Surg Laser SystemGEX · Traditional 03/01/1994SE
K922496Trimedyne Model 1210 Omnipulse Holmium Laser SystGEX · Traditional 03/01/1994SE
K923191Switchable Tip SystemGEX · Traditional 03/31/1993SE
K922213Laser-Assisted Disk Decompression Accessory PackGEX · Traditional 03/20/1993SE
K920934Halocath Laser CathetersGEX · Traditional 04/29/1992SE
K920632Side Firing FibersGEX · Traditional 04/02/1992SE
K920625LateralaseGEX · Traditional 04/02/1992SE
K915117Model 1210 Omnipulse Holmium Laser SystemGEX · Traditional 04/02/1992SE
K915354LateralaseGEX · Traditional 02/24/1992SE
K915223Metal Enclosed Side Firing FibersGEX · Traditional 01/23/1992SE
K914952Model 1210 Omnipulse Holmium Laser SystemGEX · Traditional 12/20/1991SE
K913109Lateralase(Tm) Catheter with Thermal FeedbackGEX · Traditional 10/08/1991SE
K911457Trimedyne Model 1210 Omnipulse Holmium Laser SystGEX · Traditional 09/05/1991SE
K903418Lateralase TMGEX · Traditional 06/24/1991SE
K905708Trimedyne Model 1210 Omnipulse Laser SystemGEX · Traditional 03/28/1991SE
K903838Optilase (TM) Model 900 ArgonGEX · Traditional 03/05/1991SE
K903154Contact Fibers,Surgical Probes & Non-Contact FiberGEX · Traditional 11/23/1990SE
K902940Cardiolase Yag Model 4000 Surgical Laser SystemGEX · Traditional 10/03/1990SE
K902939Optilase Yag Model 1000 Surgical Laser SystemGEX · Traditional 10/03/1990SE
K902263Optilase Model 1000 Nd:Yag Laser Add'L IndicationGGX · Traditional 07/23/1990SE
K895538Angioscope W/The OPTISCOPE-2 Integrated AngioscopyLYK · Traditional 04/26/1990SE
K897157Optilase Yag Model 1000 Acv Surgical Laser SystemGEX · Traditional 02/22/1990SE
K895874Optilase Yag Model 1000GEX · Traditional 01/03/1990SE
K895774Gyn-ProbeGEX · Traditional 01/03/1990SE
K894977Optilase Yag Model 1000 Surgical Laser SystemGEX · Traditional 10/10/1989SE
K890279Modified Model 1000 Optilase(Tm) Nd:Yag LaserGEX · Traditional 02/07/1989SE
K870505Optilase Yag Model 1000 Surg Laser Sys/Pulmon ApplLLO · Traditional 08/07/1987SE
K861331Endoscopic Electrosurgical Fiberoptic ProbeLNK · Traditional 08/07/1986SE
K861173Optilase Yag Model 1000 Surg Laser System/GastroLNK · Traditional 07/25/1986SE
K843628Hotip Hemostatic ProbeLNK · Traditional 11/12/1985SE
K851405Trimedyne Medical Argon Laser System Model 700GEX · Traditional 10/07/1985SE
K841318A.S.A.P.LDR · Traditional 07/18/1984SE
K840722EnteroscopeFDA · Traditional 06/07/1984SE
K830084AngioscopeLYK · Traditional 06/02/1983SE
K810605Chematic Bicarbonate Dialysate SystemFKR · Traditional 06/16/1981SE

PMA approvals