K964005 is an FDA 510(k) clearance for the SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE. This device is classified as a Endoilluminator (Class II - Special Controls, product code MPA).
Submitted by Synergetics, Inc. (Chesterfield, US). The FDA issued a Cleared decision on June 9, 1997, 275 days after receiving the submission on September 7, 1996.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K964005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1996 |
| Decision Date | June 09, 1997 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MPA — Endoilluminator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |