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Parker Quality & Compliance

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510(k) clearance

Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview 60 UV toric (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview 60 UV multifocal (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

FDA 510(k) source

510(k) number
K260311
Applicant
St. shine Optical Co., Ltd.
Decision date
Oct 28, 2026
Date received
Jan 30, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
LPL
Device type
Lenses, Soft Contact, Daily Wear
Device class
Class II
Regulation
21 CFR 886.5925
Advisory committee
Ophthalmic
Statement or summary
Summary
Third party
N
Location
New Taipei City, TW