PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK)— 510(k) K971515

Substantially Equivalent

Biomed Devices Corp.

FDA 510(k) clearance K971515 for PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK), Substantially Equivalent on 1997-05-20. Applicant: Biomed Devices Corp..

Clearance details

Applicant: Biomed Devices Corp.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1997-04-25
Decision date: 1997-05-20
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.