The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model 1210-vhp And 1500-a.
| Device ID | K002308 |
| 510k Number | K002308 |
| Device Name: | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine, CA 92619 -7001 |
| Contact | Susan H Gamble |
| Correspondent | Susan H Gamble TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine, CA 92619 -7001 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-28 |
| Decision Date | 2000-12-20 |