K800238 is an FDA 510(k) clearance for the MOIRE FRINGE VISOMETER AFTER LOTMAR. This device is classified as a Retinoscope, Ac-powered (Class II - Special Controls, product code HKL).
Submitted by Hagg-Streit Service, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1980, 34 days after receiving the submission on February 5, 1980.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1780.
| 510(k) Number | K800238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1980 |
| Decision Date | March 10, 1980 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HKL — Retinoscope, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1780 |