AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS— 510(k) K954139

Substantially Equivalent

CooperVision, Inc.

FDA 510(k) clearance K954139 for AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS, Substantially Equivalent on 1995-11-24. Applicant: CooperVision, Inc..

Clearance details

Applicant: CooperVision, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1995-09-01
Decision date: 1995-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.