510(k) K191795

AOCup Lens Case with AODisc by Alcon Laboratories, Inc. — Product Code LPN

K191795 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "AOCup Lens Case with AODisc". The FDA issued a decision of Substantially Equivalent on July 31, 2019. 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
July 31, 2019
Date Received
July 3, 2019
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