Submission Details
| 510(k) Number | K022687 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 13, 2002 |
| Decision Date | November 19, 2002 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
Nov 2002
Decision
98d
Days
Class 2
Risk
About This 510(k) Submission
K022687 is an FDA 510(k) clearance for the AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION, a Accessories, Solution, Ultrasonic Cleaners For Lenses (Class II — Special Controls, product code LYL), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on November 19, 2002, 98 days after receiving the submission on August 13, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LYL — Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
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