PolyDev Soft Contact Lenses— 510(k) K160977

Substantially Equivalent

Polydev , Ltd.

FDA 510(k) clearance K160977 for PolyDev Soft Contact Lenses, Substantially Equivalent on 2016-07-13. Applicant: Polydev , Ltd..

Clearance details

Applicant: Polydev , Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2016-04-07
Decision date: 2016-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Collon, IE

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.