510(k) K051900

ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR by Johnson & Johnson Vision Care, Inc. — Product Code MVN

K051900 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Vision Care, Inc. for the device "ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR". The FDA issued a decision of Substantially Equivalent on August 12, 2005. The device falls under product code MVN (Lens, Contact, (Disposable)), 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
August 12, 2005
Date Received
July 13, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, (Disposable)
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type