510(k) K180398

Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal by Alcon Laboratories, Inc. — Product Code LPL

K180398 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal". The FDA issued a decision of Substantially Equivalent on Apr 10, 2018. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Alcon Laboratories, Inc. has 89 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 10, 2018
Date Received
Feb 13, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type
510(k)