SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)— 510(k) K132146

Substantially Equivalent

St. shine Optical Co., Ltd.

FDA 510(k) clearance K132146 for SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A), Substantially Equivalent on 2013-08-30. Applicant: St. shine Optical Co., Ltd..

Clearance details

Applicant: St. shine Optical Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2013-07-11
Decision date: 2013-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei Hsien, TW

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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.