K251573

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens

510(k) number
K251573
Device name
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
Applicant
Vizionfocus, Inc. TW
Product code
LPL — Lenses, Soft Contact, Daily Wear
Decision date
2025-09-10
Date received
2025-05-22
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K251573.pdf

Official FDA record: K251573
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.