K113852 is an FDA 510(k) clearance for the BAUSCH & LOMB IOL INJECTOR. This device is classified as a Folders And Injectors, Intraocular Lens (iol) (Class I - General Controls, product code MSS).
Submitted by Bausch & Lomb, Inc. (Alusi Vuejo, US). The FDA issued a Cleared decision on September 28, 2012, 274 days after receiving the submission on December 29, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300.
| 510(k) Number | K113852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2011 |
| Decision Date | September 28, 2012 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MSS - Folders And Injectors, Intraocular Lens (iol) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4300 |