SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS— 510(k) K121201

Substantially Equivalent

St. shine Optical Co., Ltd.

FDA 510(k) clearance K121201 for SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS, Substantially Equivalent on 2012-10-26. Applicant: St. shine Optical Co., Ltd..

Clearance details

Applicant: St. shine Optical Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2012-04-19
Decision date: 2012-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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.