510(k) K171447

OxyPure Color Silicone Hydrogel Soft Contact Lenses by Visco Vision, Inc. — Product Code LPL

K171447 is an FDA 510(k) premarket notification submitted by Visco Vision, Inc. for the device "OxyPure Color Silicone Hydrogel Soft Contact Lenses". The FDA issued a decision of Substantially Equivalent on Dec 5, 2017. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Visco Vision, Inc. has 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 5, 2017
Date Received
May 16, 2017
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)