Submission Details
| 510(k) Number | K063331 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Abbreviated
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
Dec 2006
Decision
46d
Days
Class 2
Risk
About This 510(k) Submission
K063331 is an FDA 510(k) clearance for the BAUSCH & LOMB NGX MICROSURGICAL SYSTEM, 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 review panel. Regulated under 21 CFR 886.4670.
Device Classification
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4670 |
Manufacturer
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