Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens— 510(k) K181558

Substantially Equivalent

Gelflex Laboratories

FDA 510(k) clearance K181558 for Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens, Substantially Equivalent on 2018-09-06. Applicant: Gelflex Laboratories.

Clearance details

Applicant: Gelflex Laboratories
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2018-06-13
Decision date: 2018-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malaga, AU

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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.