The following data is part of a premarket notification filed by Eyesys Laboratories, Inc. with the FDA for Corneal Analysis Systems(tm).
| Device ID | K924032 |
| 510k Number | K924032 |
| Device Name: | CORNEAL ANALYSIS SYSTEMS(TM) |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | EYESYS LABORATORIES, INC. 2776 BINGLE RD. Houston, TX 77055 |
| Contact | Kenneth Carbonari |
| Correspondent | Kenneth Carbonari EYESYS LABORATORIES, INC. 2776 BINGLE RD. Houston, TX 77055 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-11 |
| Decision Date | 1993-03-18 |