TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
TRIMEDYNE, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1419951 | 1419951 | TRIMEDYNE, INC. | 1 | N | 2026-01-01 | 519 N. Smith Avenue, Suite 105 Corona CA US 92878 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M4731210VHP0 | Trimedyne® 1210-VHP OmniPulse Max™ Holmium Laser System - Model 1210-VHP - OmniPulse Max Holmium Laser System | 8007335273 | customerservice@trimedyne.com |
| M47320462HP0 | Trimedyne® OmniTip™ 25 cm Side Firing Laser Needle - SwitchTip, Sidefire, 25cm | 8007335273 | customerservice@trimedyne.com |
| M47320474HP0 | Trimedyne® OmniTip™ Switchable Tip - Straight - Tip, Switchable, Omni HP System, 0 degree | 8007335273 | customerservice@trimedyne.com |
| M47320475HP0 | Trimedyne® OmniTip™ Switchable Tip - 20° - Tip, Switchable, Omni HP System, 20 degree | 8007335273 | customerservice@trimedyne.com |
| M47320475MHP0 | Trimedyne® Reposable OmniTip™ Switchable Tip - 20° - Multiuse Switchable Tip, Omni HP System, 20 degree | 8007335273 | customerservice@trimedyne.com |
| M47320476HP0 | Trimedyne® OmniTip™ Switchable Tip - 30° - Tip, Switchable, Omni HP System, 30 degree | 8007335273 | customerservice@trimedyne.com |
| M47320476MHP0 | Trimedyne® Reposable OmniTip™ Switchable Tip - 30° - Multiuse Switchable Tip, Omni HP System, 30 degree | 8007335273 | customerservice@trimedyne.com |
| M47321200 | Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System - Model 2120 - OmniPulse Mini Holmium Laser System | 8007335273 | customerservice@trimedyne.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 69077 | 1812998041 | K992574 | OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A | GEX | 1999-10-29 |
| 69077 | 1621595699 | K992230 | OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP | GEX | 1999-07-12 |
| 69077 | 1954138272 | K973172 | RESPOSABLE BARE FIBERS | GEX | 1998-02-03 |
| 69077 | 2032236119 | K962632 | OMNIPULSE/OMNIPULSE-MAX | GEX | 1997-01-16 |
| 69077 | 1798168435 | K951562 | OMNIPULSE-MAX HOLMIUM LASER | GEX | 1995-07-21 |
| 69077 | 1187395761 | K941419 | DISPOSABLE SPINAL INTRODUCER SHEATH | GEX | 1994-06-21 |
| 69077 | 1508188526 | K934865 | OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM | GEX | 1994-05-12 |
| 69077 | 1154369056 | K925124 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST | GEX | 1994-03-01 |
| 69077 | 1099889029 | K923191 | SWITCHABLE TIP SYSTEM | GEX | 1993-03-31 |
| 69077 | 1741221959 | K922496 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST | GEX | 1994-03-01 |
| 69077 | 1344188091 | K915117 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM | GEX | 1992-04-02 |
| 69077 | 1620049885 | K914952 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM | GEX | 1991-12-20 |
| 69077 | 1023843925 | K911457 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST | GEX | 1991-09-05 |
| 69077 | 2037273832 | K903154 | CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER | GEX | 1990-11-23 |
| 69077 | 1708704828 | K053457 | VAPORMAX II | GEX | 2005-12-21 |
| 69077 | 1752191465 | K043012 | OMNIPULSE MINI, MODEL 2120 | GEX | 2004-11-17 |
| 69077 | 1481641641 | K041660 | TRIMEDYNE HOLMIUM LASER SYSTEMS | GEX | 2004-09-08 |
| 69077 | 1520605047 | K022655 | TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH | GEX | 2002-11-07 |
| 69077 | 1765028451 | K013974 | RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A | GEX | 2002-09-23 |
| 69077 | 1035978327 | K002308 | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A | GEX | 2000-12-20 |
| 69077 | 1829747997 | K001676 | OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A | GEX | 2000-11-02 |
| 69077 | 1180918219 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEX | 21 | 2005-12-21 |
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
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TRIMEDYNE, INC.
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TRIMEDYNE, INC.
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TRIMEDYNE, INC.
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TRIMEDYNE, INC.
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TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
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TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
Trimedyne, Inc.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
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TRIMEDYNE, INC.
TRIMEDYNE, INC.
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TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
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TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
TRIMEDYNE, INC.
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