510(k) K210930

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) by Johnson & Johnson Vision Care, Inc. — Product Code LPL

K210930 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Vision Care, Inc. for the device "ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)". The FDA issued a decision of Substantially Equivalent on November 29, 2021. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Johnson & Johnson Vision Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2021
Date Received
March 29, 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