K242413

VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens

510(k) number
K242413
Device name
VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens
Applicant
Vizionfocus, Inc. TW
Product code
LPL — Lenses, Soft Contact, Daily Wear
Decision date
2024-12-17
Date received
2024-08-14
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K242413.pdf

Official FDA record: K242413
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.