K252385

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

510(k) number
K252385
Device name
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
Applicant
Pegavision Corporation TW
Product code
LPL — Lenses, Soft Contact, Daily Wear
Decision date
2026-03-13
Date received
2025-07-31
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K252385.pdf

Official FDA record: K252385
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.