K063694 is an FDA 510(k) clearance for the AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28. This device is classified as a Lens, Guide, Intraocular (Class I - General Controls, product code KYB).
Submitted by Bausch & Lomb, Inc. (San Dimas, US). The FDA issued a Cleared decision on March 7, 2007, 84 days after receiving the submission on December 13, 2006.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300.
| 510(k) Number | K063694 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2006 |
| Decision Date | March 07, 2007 |
| Days to Decision | 84 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | KYB - Lens, Guide, Intraocular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4300 |