Submission Details
| 510(k) Number | K030522 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 2003 |
| Decision Date | September 12, 2003 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
Sep 2003
Decision
205d
Days
Class 2
Risk
About This 510(k) Submission
K030522 is an FDA 510(k) clearance for the AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on September 12, 2003, 205 days after receiving the submission on February 19, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
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