K812051 is an FDA 510(k) clearance for the PHOTOLITE AOLITE TINTOMATIC LENS. This device is classified as a Lens, Spectacle, Non-custom (prescription) (Class I - General Controls, product code HQG).
Submitted by American Optical Corp. (Walker, US). The FDA issued a Cleared decision on September 8, 1981, 49 days after receiving the submission on July 21, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5844.
| 510(k) Number | K812051 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 1981 |
| Decision Date | September 08, 1981 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQG — Lens, Spectacle, Non-custom (prescription) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.5844 |