GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT— 510(k) K024003

Substantially Equivalent

Gelflex

FDA 510(k) clearance K024003 for GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT, Substantially Equivalent on 2003-02-05. Applicant: Gelflex.

Clearance details

Applicant: Gelflex
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2002-12-04
Decision date: 2003-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, 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.