510(k) K150293

EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) by I-See Vision Technology, Inc. — Product Code LPL

K150293 is an FDA 510(k) premarket notification submitted by I-See Vision Technology, Inc. for the device "EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)". The FDA issued a decision of Substantially Equivalent on Apr 15, 2015. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. I-See Vision Technology, Inc. has 3 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 15, 2015
Date Received
Feb 6, 2015
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
510(k)

Source: FDA 510(k) database entry for K150293. Report a data issue: hello@regdatalab.com.