K250364

Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

510(k) number
K250364
Device name
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
Applicant
St. shine Optical Co., Ltd. TW
Product code
LPL — Lenses, Soft Contact, Daily Wear
Decision date
2025-10-07
Date received
2025-02-10
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ophthalmic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain

Also available from FDA: K250364.pdf

Official FDA record: K250364
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.