EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS— 510(k) K041957

Substantially Equivalent

Diomed, Inc.

FDA 510(k) clearance K041957 for EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS, Substantially Equivalent on 2004-12-01. Applicant: Diomed, Inc..

Clearance details

Applicant: Diomed, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2004-07-21
Decision date: 2004-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Reading, MA, US

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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.