K782118 is an FDA 510(k) clearance for the FUL-VUE. This device is classified as a Refractor, Manual, Non-powered, Including Phoropter (Class I - General Controls, product code HKN).
Submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1979, 30 days after receiving the submission on December 27, 1978.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1770.
| 510(k) Number | K782118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1978 |
| Decision Date | January 26, 1979 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HKN — Refractor, Manual, Non-powered, Including Phoropter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1770 |