510(k) K073060

CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR by Innova Vision, Inc. — Product Code MVN

K073060 is an FDA 510(k) premarket notification submitted by Innova Vision, Inc. for the device "CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR". The FDA issued a decision of Substantially Equivalent on November 29, 2007. The device falls under product code MVN (Lens, Contact, (Disposable)), a Class II device regulated under 21 CFR 886.5925. Innova Vision, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2007
Date Received
October 30, 2007
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