510(k) K223585— Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear

Substantially Equivalent

Yung Sheng Optical Co., Ltd.

Clearance details

Applicant: Yung Sheng Optical Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2022-12-01
Decision date: 2023-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung 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.