510(k) K141670

ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA by Johnson & Johnson Vision Care, Inc. — Product Code LPL

K141670 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Vision Care, Inc. for the device "ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA". The FDA issued a decision of Substantially Equivalent on September 18, 2014. 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
September 18, 2014
Date Received
June 23, 2014
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