Last synced on 14 November 2025 at 11:06 pm

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

Page Type
Cleared 510(K)
510(k) Number
K162317
510(k) Type
Traditional
Applicant
ST. SHINE OPTICAL CO., LTD.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
10/21/2016
Days to Decision
63 days
Submission Type
Summary

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

Page Type
Cleared 510(K)
510(k) Number
K162317
510(k) Type
Traditional
Applicant
ST. SHINE OPTICAL CO., LTD.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
10/21/2016
Days to Decision
63 days
Submission Type
Summary