510(k) K022687
K022687 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION". The FDA issued a decision of Substantially Equivalent on November 19, 2002. The device falls under product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses), a Class II device regulated under 21 CFR 886.5928. Ciba Vision Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2002
- Date Received
- August 13, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Solution, Ultrasonic Cleaners For Lenses
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type