K961658 is an FDA 510(k) clearance for the MEGATRON OPHTHALMIC SURGICAL SYSTEM. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Intl. Ophthalmic Industries Corp. (Centerville, US). The FDA issued a Cleared decision on July 23, 1996, 85 days after receiving the submission on April 29, 1996.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K961658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1996 |
| Decision Date | July 23, 1996 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |