(LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT— 510(k) K964528

Substantially Equivalent

Benz Research and Development Corp.

FDA 510(k) clearance K964528 for (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT, Substantially Equivalent on 1997-03-07. Applicant: Benz Research and Development Corp..

Clearance details

Applicant: Benz Research and Development Corp.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1996-11-12
Decision date: 1997-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosewell, GA, 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.