The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Ophthalmic Surgical System.
| Device ID | K935223 |
| 510k Number | K935223 |
| Device Name: | OPHTHALMIC SURGICAL SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | OPTICAL MICRO SYSTEMS, INC. 86 BOSTON POST RD. Waterford, CT 06385 |
| Contact | Ronald Luich |
| Correspondent | Ronald Luich OPTICAL MICRO SYSTEMS, INC. 86 BOSTON POST RD. Waterford, CT 06385 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-01 |
| Decision Date | 1994-03-14 |