The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Sun Photo-keratoscope.
| Device ID | K831084 |
| 510k Number | K831084 |
| Device Name: | SUN PHOTO-KERATOSCOPE |
| Classification | Keratoscope, Ac-powered |
| Applicant | NIDEK, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-04 |
| Decision Date | 1983-06-30 |