K063331 is an FDA 510(k) clearance for the BAUSCH & LOMB NGX MICROSURGICAL 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 December 19, 2006, 46 days after receiving the submission on November 3, 2006.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K063331 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2006 |
| Decision Date | December 19, 2006 |
| Days to Decision | 46 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |