Trimedyne, Inc.

Corona, CA, US

TRIMEDYNE, INC. appears in FDA device records in Corona, CA. FDA records list 58 510(k) clearances between 1981-06-16 and 2005-12-21, 43 PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 58
PMA records: 43
Recall records: 0
Registered establishments: 1

510(k) clearance history

Showing 50 of 58

FDA records hold 58 510(k) clearances for Trimedyne, Inc. between 1981 and 2005. The busiest year on record is 1990, with 8. The most recent is 2005, with 2.

Clearances by year, as a table

510(k) clearance decisions for Trimedyne, Inc., by decision year
Year	Clearances
1981	1
1983	1
1984	2
1985	2
1986	2
1987	1
1989	2
1990	8
1991	6
1992	6
1993	2
1994	8
1995	2
1996	1
1997	3
1998	1
1999	2
2000	2
2002	2
2004	2
2005	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K053457	VAPORMAX II	GEX	Substantially Equivalent	2005-12-21
K050412	VAPORMAX	GEX	Substantially Equivalent	2005-03-14
K043012	OMNIPULSE MINI, MODEL 2120	GEX	Substantially Equivalent	2004-11-17
K041660	TRIMEDYNE HOLMIUM LASER SYSTEMS	GEX	Substantially Equivalent	2004-09-08
K022655	TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH	GEX	Substantially Equivalent	2002-11-07
K013974	RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A	GEX	Substantially Equivalent	2002-09-23
K002308	OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A	GEX	Substantially Equivalent	2000-12-20
K001676	OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A	GEX	Substantially Equivalent	2000-11-02
K992574	OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A	GEX	Substantially Equivalent	1999-10-29
K992230	OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP	GEX	Substantially Equivalent	1999-07-12
K973172	RESPOSABLE BARE FIBERS	GEX	Substantially Equivalent	1998-02-03
K970422	RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS	GEX	Substantially Equivalent	1997-04-21
K964585	RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)	GEX	Substantially Equivalent	1997-04-17
K962632	OMNIPULSE/OMNIPULSE-MAX	GEX	Substantially Equivalent	1997-01-16
K954597	RIGHT ANGLE LASER FIBERS	GEX	Substantially Equivalent	1996-03-11
K953494	TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY	GEX	Substantially Equivalent	1995-09-14
K951562	OMNIPULSE-MAX HOLMIUM LASER	GEX	Substantially Equivalent	1995-07-21
K944204	LATERALASE, MODIFIED	GEX	Substantially Equivalent	1994-11-28
K941419	DISPOSABLE SPINAL INTRODUCER SHEATH	GEX	Substantially Equivalent	1994-06-21
K932883	OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM	GEX	Substantially Equivalent	1994-06-21
K934865	OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM	GEX	Substantially Equivalent	1994-05-12
K925414	LATERALASE CATHETER	GEX	Substantially Equivalent	1994-03-01
K925124	TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST	GEX	Substantially Equivalent	1994-03-01
K922497	OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM	GEX	Substantially Equivalent	1994-03-01
K922496	TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST	GEX	Substantially Equivalent	1994-03-01
K923191	SWITCHABLE TIP SYSTEM	GEX	Substantially Equivalent	1993-03-31
K922213	LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK	GEX	Substantially Equivalent	1993-03-20
K920934	HALOCATH LASER CATHETERS	GEX	Substantially Equivalent	1992-04-29
K920632	SIDE FIRING FIBERS	GEX	Substantially Equivalent	1992-04-02
K920625	LATERALASE	GEX	Substantially Equivalent	1992-04-02
K915117	MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM	GEX	Substantially Equivalent	1992-04-02
K915354	LATERALASE	GEX	Substantially Equivalent	1992-02-24
K915223	METAL ENCLOSED SIDE FIRING FIBERS	GEX	Substantially Equivalent	1992-01-23
K914952	MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM	GEX	Substantially Equivalent	1991-12-20
K913109	LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK	GEX	Substantially Equivalent	1991-10-08
K911457	TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST	GEX	Substantially Equivalent	1991-09-05
K903418	LATERALASE TM	GEX	Substantially Equivalent	1991-06-24
K905708	TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM	GEX	Substantially Equivalent	1991-03-28
K903838	OPTILASE (TM) MODEL 900 ARGON	GEX	Substantially Equivalent	1991-03-05
K903154	CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER	GEX	Substantially Equivalent	1990-11-23
K902940	CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM	GEX	Substantially Equivalent	1990-10-03
K902939	OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM	GEX	Substantially Equivalent	1990-10-03
K902263	OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION	GGX	Substantially Equivalent	1990-07-23
K895538	ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY	LYK	Substantially Equivalent	1990-04-26
K897157	OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM	GEX	Substantially Equivalent	1990-02-22
K895874	OPTILASE YAG MODEL 1000	GEX	Substantially Equivalent	1990-01-03
K895774	GYN-PROBE	GEX	Substantially Equivalent	1990-01-03
K894977	OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM	GEX	Substantially Equivalent	1989-10-10
K890279	MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER	GEX	Substantially Equivalent	1989-02-07
K870505	OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL	LLO	Substantially Equivalent	1987-08-07

Registered establishments

FDA registered establishments for Trimedyne, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1419951	1419951	TRIMEDYNE, INC.	519 N. Smith Avenue, Suite 105, Corona, CA 92878 US	2026	FSM GBX GCX GEX

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain