K244009

Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)

510(k) number: K244009
Device name: Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)
Applicant: Yung Sheng Optical Co., Ltd. TW
Product code: LPL — Lenses, Soft Contact, Daily Wear
Decision date: 2025-09-25
Date received: 2024-12-26
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: K244009.pdf

Official FDA record: K244009

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