The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Modified Model 1000 Optilase(tm) Nd:yag Laser.
| Device ID | K890279 |
| 510k Number | K890279 |
| Device Name: | MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin, CA 92680 |
| Contact | Kimberley Doney |
| Correspondent | Kimberley Doney TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin, CA 92680 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-12 |
| Decision Date | 1989-02-07 |