K113857 is an FDA 510(k) clearance for the SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE. This device is classified as a Photocoagulator And Accessories (Class II - Special Controls, product code HQB).
Submitted by Synergetics, Inc. (O' Fallon, US). The FDA issued a Cleared decision on April 23, 2012, 115 days after receiving the submission on December 30, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4690.
| 510(k) Number | K113857 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2011 |
| Decision Date | April 23, 2012 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQB — Photocoagulator And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4690 |