K844373 is an FDA 510(k) clearance for the O.M.S. ULTRA-PHACO. This device is classified as a Unit, Phacofragmentation (Class II — Special Controls, product code HQC).
Submitted by Optical Micro Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on December 19, 1985, 401 days after receiving the submission on November 13, 1984.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K844373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1984 |
| Decision Date | December 19, 1985 |
| Days to Decision | 401 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4670 |