GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS— 510(k) K011072

Substantially Equivalent

Gelflex

FDA 510(k) clearance K011072 for GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS, Substantially Equivalent on 2001-08-24. Applicant: Gelflex.

Clearance details

Applicant: Gelflex
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2001-04-09
Decision date: 2001-08-24
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.