The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Ophthalas 532 Solid State Photocoagulator.
| Device ID | K932062 |
| 510k Number | K932062 |
| Device Name: | OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | David W Krapf |
| Correspondent | David W Krapf 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 | 1993-04-29 |
| Decision Date | 1994-03-18 |