Data / Medical devices / United States / Trimedyne, Inc.
Trimedyne, Inc.: FDA-registered device maker in Corona, CA, United States, 21 510(k) clearances
Trimedyne, Inc. is registered with the FDA (registration 1419951) in Corona, CA, United States. It lists 4 device types. The FDA files 21 510(k) clearances under its listings, the newest dated December 21, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1419951
- Address
- 519 N. Smith Avenue, Suite 105, Corona, CA, United States, 92878
- Owner or operator
- TRIMEDYNE, INC. (9920133)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 26, 2002
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 21, 2005 | K053457 | VAPORMAX II | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| November 17, 2004 | K043012 | OMNIPULSE MINI, MODEL 2120 | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| September 8, 2004 | K041660 | TRIMEDYNE HOLMIUM LASER SYSTEMS | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| November 7, 2002 | K022655 | TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| September 23, 2002 | K013974 | RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| December 20, 2000 | K002308 | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| November 2, 2000 | K001676 | OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| October 29, 1999 | K992574 | OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| July 12, 1999 | K992230 | OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| February 3, 1998 | K973172 | RESPOSABLE BARE FIBERS | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| January 16, 1997 | K962632 | OMNIPULSE/OMNIPULSE-MAX | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| July 21, 1995 | K951562 | OMNIPULSE-MAX HOLMIUM LASER | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| June 21, 1994 | K941419 | DISPOSABLE SPINAL INTRODUCER SHEATH | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| May 12, 1994 | K934865 | OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| March 1, 1994 | K925124 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| March 1, 1994 | K922496 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| March 31, 1993 | K923191 | SWITCHABLE TIP SYSTEM | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| April 2, 1992 | K915117 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| December 20, 1991 | K914952 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| September 5, 1991 | K911457 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
| November 23, 1990 | K903154 | CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Catheter, Irrigation
- All makers of Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- All makers of Tray, Surgical, Instrument
Updated December 21, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.