Submission Details
| 510(k) Number | K031521 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 15, 2003 |
| Decision Date | June 27, 2003 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
Jun 2003
Decision
43d
Days
Class 2
Risk
About This 510(k) Submission
K031521 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 June 27, 2003, 43 days after receiving the submission on May 15, 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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