The following data is part of a premarket notification filed by Kera Corp. with the FDA for Corneascope Model 1200.
| Device ID | K850665 |
| 510k Number | K850665 |
| Device Name: | CORNEASCOPE MODEL 1200 |
| Classification | Keratoscope, Ac-powered |
| Applicant | KERA CORP. 2362 WALSH AVE. Santa Clara, CA 95051 |
| Contact | Collins |
| Correspondent | Collins KERA CORP. 2362 WALSH AVE. Santa Clara, CA 95051 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-20 |
| Decision Date | 1985-03-20 |