K033941 is an FDA 510(k) clearance for the MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Bausch & Lomb, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 10, 2004, 53 days after receiving the submission on December 19, 2003.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K033941 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2003 |
| Decision Date | February 10, 2004 |
| Days to Decision | 53 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 |