BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens— 510(k) K220143

Substantially Equivalent

Shenzhen Dashicheng Optical Technology Co., Ltd.

FDA 510(k) clearance K220143 for BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens, Substantially Equivalent on 2022-09-08. Applicant: Shenzhen Dashicheng Optical Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Dashicheng Optical Technology Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2022-01-18
Decision date: 2022-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.