K163632 is an FDA 510(k) clearance for the Katalyst Cyclophotocoagulation Probe. This device is classified as a Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (Class II - Special Controls, product code LQJ).
Submitted by Katalyst Surgical, LLC (Chesterfield, US). The FDA issued a Cleared decision on June 15, 2017, 175 days after receiving the submission on December 22, 2016.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K163632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2016 |
| Decision Date | June 15, 2017 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LQJ - Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |