510(k) 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

Substantially Equivalent

St. shine Optical Co., Ltd.

Clearance details

Applicant: St. shine Optical Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2025-02-10
Decision date: 2025-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.