K140362 is an FDA 510(k) clearance for the KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Katalyst Surgical, LLC (Chesterfield, US). The FDA issued a Cleared decision on September 15, 2014, 215 days after receiving the submission on February 12, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K140362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2014 |
| Decision Date | September 15, 2014 |
| Days to Decision | 215 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |