The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Right Angle Laser Fibers;optilase Nd:yag Laser;optilase Pl100 Nd Laser Systems.
| Device ID | K970422 |
| 510k Number | K970422 |
| Device Name: | RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine, CA 92619 -7001 |
| Contact | Susam H Gamble |
| Correspondent | Susam 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 | 1997-02-03 |
| Decision Date | 1997-04-21 |
| Summary: | summary |