K133562 is an FDA 510(k) clearance for the CATARHEX 3. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Oertli Instrumente AG (Berneck, CH). The FDA issued a Cleared decision on August 12, 2014, 265 days after receiving the submission on November 20, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K133562 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2013 |
| Decision Date | August 12, 2014 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |