CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR— 510(k) K013201

Substantially Equivalent

Cardiofocus, Inc.

FDA 510(k) clearance K013201 for CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR, Substantially Equivalent on 2002-03-18. Applicant: Cardiofocus, Inc..

Clearance details

Applicant: Cardiofocus, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2001-09-25
Decision date: 2002-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South West Ranches, FL, 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.