510(k) K222954

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens by Innova Vision, Inc. — Product Code LPL

K222954 is an FDA 510(k) premarket notification submitted by Innova Vision, Inc. for the device "Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens". The FDA issued a decision of Substantially Equivalent on March 13, 2023. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), 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
March 13, 2023
Date Received
September 27, 2022
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