K220263 is an FDA 510(k) clearance for the Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers. This device is classified as a Photocoagulator And Accessories (Class II - Special Controls, product code HQB).
Submitted by Vortex Surgical, Inc. (Chesterfield, US). The FDA issued a Cleared decision on November 3, 2022, 276 days after receiving the submission on January 31, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4690.
| 510(k) Number | K220263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2022 |
| Decision Date | November 03, 2022 |
| Days to Decision | 276 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 |