510(k) K142284

CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE by Alcon Laboratories, Inc. — Product Code LPN

K142284 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE". The FDA issued a decision of Substantially Equivalent on January 26, 2015. 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
January 26, 2015
Date Received
August 18, 2014
Clearance Type
Traditional
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