FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS— 510(k) K133403

Substantially Equivalent

Firestone Optics, Inc.

FDA 510(k) clearance K133403 for FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS, Substantially Equivalent on 2014-06-11. Applicant: Firestone Optics, Inc..

Clearance details

Applicant: Firestone Optics, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2013-11-06
Decision date: 2014-06-11
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.