LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D— 510(k) K052777

Substantially Equivalent

Ellex Medical Pty, Ltd.

FDA 510(k) clearance K052777 for LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D, Substantially Equivalent on 2006-03-16. Applicant: Ellex Medical Pty, Ltd..

Clearance details

Applicant: Ellex Medical Pty, Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2005-10-03
Decision date: 2006-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Adelaide, South Australia, AU

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.