K121187 is an FDA 510(k) clearance for the KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Katalyst Surgical, LLC (Washington, US). The FDA issued a Cleared decision on September 17, 2012, 151 days after receiving the submission on April 19, 2012.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K121187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2012 |
| Decision Date | September 17, 2012 |
| Days to Decision | 151 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 |