The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Omnipulse Model 1210-vhp Ho:yag Laser System.
| Device ID | K934865 |
| 510k Number | K934865 |
| Device Name: | OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine, CA 92714 -5114 |
| Contact | Louie Goryoka |
| Correspondent | Louie Goryoka 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 | 1993-10-12 |
| Decision Date | 1994-05-12 |