SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens— 510(k) K151847

Substantially Equivalent

Smart Performer Corp. , Ltd.

FDA 510(k) clearance K151847 for SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens, Substantially Equivalent on 2016-03-04. Applicant: Smart Performer Corp. , Ltd..

Clearance details

Applicant: Smart Performer Corp. , Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2015-07-07
Decision date: 2016-03-04
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.