The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Ophthalas 532 Solid State Photocoagulator, Or Equivalent Laser Systems.
| Device ID | K962592 |
| 510k Number | K962592 |
| Device Name: | OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | Martin A Kaufman |
| Correspondent | Martin A Kaufman ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-02 |
| Decision Date | 1996-09-23 |
| Summary: | summary |