510(k) K030027— GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%

Substantially Equivalent

Gelflex Laboratories

Clearance details

Applicant: Gelflex Laboratories
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2003-01-03
Decision date: 2003-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, Western, Wa, AU

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.