The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Rmnipulse Holmium Laser System/1210; Max/1210-vhp; Jr. 1230-30; N/a 1500-a.
| Device ID | K013974 |
| 510k Number | K013974 |
| Device Name: | RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 15091 BAKE PKWY. Irvine, CA 92606 |
| Contact | Susan H Gamble |
| Correspondent | Susan H Gamble TRIMEDYNE, INC. 15091 BAKE PKWY. Irvine, CA 92606 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-03 |
| Decision Date | 2002-09-23 |
| Summary: | summary |