PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)— 510(k) K010126

Substantially Equivalent

Cl-Tinters

FDA 510(k) clearance K010126 for PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED), Substantially Equivalent on 2001-03-12. Applicant: Cl-Tinters.

Clearance details

Applicant: Cl-Tinters
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2001-01-16
Decision date: 2001-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colts Neck, NJ, US

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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.