Submission Details
| 510(k) Number | K082473 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 27, 2008 |
| Decision Date | January 05, 2009 |
| Days to Decision | 131 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Abbreviated
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
Jan 2009
Decision
131d
Days
Class 2
Risk
About This 510(k) Submission
K082473 is an FDA 510(k) clearance for the BAUSCH & LOMB STELLARIS 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 January 5, 2009, 131 days after receiving the submission on August 27, 2008. 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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