FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)— 510(k) K971049

Substantially Equivalent

Aspect Vision Care, Ltd.

FDA 510(k) clearance K971049 for FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED), Substantially Equivalent on 1997-05-21. Applicant: Aspect Vision Care, Ltd..

Clearance details

Applicant: Aspect Vision Care, Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1997-03-21
Decision date: 1997-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freehold, 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.