Submission Details
| 510(k) Number | K082944 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 02, 2008 |
| Decision Date | October 16, 2008 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
Oct 2008
Decision
14d
Days
Class 1
Risk
About This 510(k) Submission
K082944 is an FDA 510(k) clearance for the CRYSTALSERT CRYSTALENS DELIVERY SYSTEM, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on October 16, 2008, 14 days after receiving the submission on October 2, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.
Device Classification
| Product Code | MSS — Folders And Injectors, Intraocular Lens (iol) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.4300 |
Manufacturer
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