510(k) K251095

Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses by Pegavision Corporation — Product Code LPL

K251095 is an FDA 510(k) premarket notification submitted by Pegavision Corporation for the device "Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses". The FDA issued a decision of Substantially Equivalent on September 17, 2025. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Pegavision Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2025
Date Received
April 10, 2025
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