The following data is part of a premarket notification filed by Xintec Corporation with the FDA for Optica 60 Nd;yag Surgical Laser System.
| Device ID | K912703 |
| 510k Number | K912703 |
| Device Name: | OPTICA 60 ND;YAG SURGICAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | XINTEC CORPORATION 900 ALICE ST. Oakland, CA 94607 |
| Contact | Marilyn Chou |
| Correspondent | Marilyn Chou XINTEC CORPORATION 900 ALICE ST. Oakland, CA 94607 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-19 |
| Decision Date | 1991-10-11 |