CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)— 510(k) K023349

Substantially Equivalent

Contamac, Ltd.

FDA 510(k) clearance K023349 for CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT), Substantially Equivalent on 2002-12-24. Applicant: Contamac, Ltd..

Clearance details

Applicant: Contamac, Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2002-10-07
Decision date: 2002-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, 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.