510(k) K212806

Alcon (serafilcon A) soft contact lenses for daily wear by Alcon Laboratories, Inc. — Product Code LPL

K212806 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "Alcon (serafilcon A) soft contact lenses for daily wear". The FDA issued a decision of Substantially Equivalent on December 28, 2021. 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2021
Date Received
September 3, 2021
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