INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE— 510(k) K053540

Substantially Equivalent

Intermedic Arfran, SA

FDA 510(k) clearance K053540 for INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE, Substantially Equivalent on 2006-09-06. Applicant: Intermedic Arfran, SA.

Clearance details

Applicant: Intermedic Arfran, SA
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2005-12-20
Decision date: 2006-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Meza, AZ, 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.