SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON— 510(k) K090806

Substantially Equivalent

Safilens, S.R.L.

FDA 510(k) clearance K090806 for SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON, Substantially Equivalent on 2009-12-18. Applicant: Safilens, S.R.L..

Clearance details

Applicant: Safilens, S.R.L.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2009-03-25
Decision date: 2009-12-18
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.