510(k) K162597

Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc by Alcon Laboratories, Inc. — Product Code LPN

K162597 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc". The FDA issued a decision of Substantially Equivalent on October 19, 2016. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2016
Date Received
September 19, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type