K101325 is an FDA 510(k) clearance for the STELLARIS PC VISION ENHANCEMENT SYSTEM. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on August 17, 2010, 97 days after receiving the submission on May 12, 2010.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K101325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2010 |
| Decision Date | August 17, 2010 |
| Days to Decision | 97 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 |