The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Omnipulse-max Holmium Laser.
| Device ID | K951562 |
| 510k Number | K951562 |
| Device Name: | OMNIPULSE-MAX HOLMIUM LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine, CA 92714 -5114 |
| Contact | Susan H Gamble |
| Correspondent | Susan H Gamble TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine, CA 92714 -5114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-04 |
| Decision Date | 1995-07-21 |