ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT— 510(k) K003161

Substantially Equivalent

Les Laboratoires Blanchard

FDA 510(k) clearance K003161 for ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT, Substantially Equivalent on 2000-12-15. Applicant: Les Laboratoires Blanchard.

Clearance details

Applicant: Les Laboratoires Blanchard
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2000-10-10
Decision date: 2000-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.