The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Optilase Model 1000-100 Nd: Yag Laser System.
| Device ID | K932883 |
| 510k Number | K932883 |
| Device Name: | OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine, CA 92714 -5114 |
| Contact | Victor Ham |
| Correspondent | Victor Ham 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 | 1993-06-14 |
| Decision Date | 1994-06-21 |