The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Trimedyne Holmium Laser Systems.
| Device ID | K041660 |
| 510k Number | K041660 |
| Device Name: | TRIMEDYNE HOLMIUM LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 15091 BAKE PKWY. Irvine, CA 92618 |
| Contact | Glenn Yeik |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-18 |
| Decision Date | 2004-09-08 |
| Summary: | summary |