K191846 is an FDA 510(k) clearance for the MAXReach Laser Probe. 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 December 23, 2019, 166 days after receiving the submission on July 10, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4690.
| 510(k) Number | K191846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2019 |
| Decision Date | December 23, 2019 |
| Days to Decision | 166 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 |