SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR— 510(k) K020917

Substantially Equivalent

St. shine Optical Co., Ltd.

FDA 510(k) clearance K020917 for SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, Substantially Equivalent on 2002-05-06. Applicant: St. shine Optical Co., Ltd..

Clearance details

Applicant: St. shine Optical Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2002-03-21
Decision date: 2002-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

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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.