The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Optilase Model 1000 Nd:yag Laser Add'l Indication.
| Device ID | K902263 |
| 510k Number | K902263 |
| Device Name: | OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION |
| Classification | Pipette, Sahli |
| Applicant | TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin, CA 92680 |
| Contact | Merritt M Girgis |
| Correspondent | Merritt M Girgis TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin, CA 92680 |
| Product Code | GGX |
| CFR Regulation Number | 864.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-21 |
| Decision Date | 1990-07-23 |