K182646 is an FDA 510(k) clearance for the Vitreq disposable laser probes, light fibers and Chandelier. This device is classified as a Photocoagulator And Accessories (Class II - Special Controls, product code HQB).
Submitted by Vitreq BV (Vierpolders, NL). The FDA issued a Cleared decision on May 1, 2019, 219 days after receiving the submission on September 24, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4690.
| 510(k) Number | K182646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2018 |
| Decision Date | May 01, 2019 |
| Days to Decision | 219 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 |