K110951 is an FDA 510(k) clearance for the 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA. This device is classified as a Photocoagulator And Accessories (Class II - Special Controls, product code HQB).
Submitted by Alcon Research, Ltd. (Irvine, US). The FDA issued a Cleared decision on October 17, 2011, 196 days after receiving the submission on April 4, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4690.
| 510(k) Number | K110951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2011 |
| Decision Date | October 17, 2011 |
| Days to Decision | 196 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 |