510(k) K232649

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

K232649 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 May 8, 2024. 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
May 8, 2024
Date Received
August 31, 2023
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