510(k) K230785

Precision1, Precision1 for Astigmatism by Alcon Laboratories, Inc. — Product Code LPL

K230785 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "Precision1, Precision1 for Astigmatism". The FDA issued a decision of Substantially Equivalent on April 20, 2023. 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
April 20, 2023
Date Received
March 22, 2023
Clearance Type
Special
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