510(k) K173538

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

K173538 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 December 4, 2017. The device falls under product code LRX (Case, Contact Lens), 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
December 4, 2017
Date Received
November 15, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type