Submission Details
| 510(k) Number | K063694 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
Mar 2007
Decision
84d
Days
Class 1
Risk
About This 510(k) Submission
K063694 is an FDA 510(k) clearance for the AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28, 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 review panel. Regulated under 21 CFR 886.4300.
Device Classification
| Product Code | KYB — Lens, Guide, Intraocular |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.4300 |
Manufacturer
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