510(k) K200243

ACUVUE (senofilcon A) Soft Contact Lens Multifocal by Johnson & Johnson Vision Care, Inc. — Product Code LPL

K200243 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Vision Care, Inc. for the device "ACUVUE (senofilcon A) Soft Contact Lens Multifocal". The FDA issued a decision of Substantially Equivalent on March 17, 2020. 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
March 17, 2020
Date Received
January 31, 2020
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