ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER— 510(k) K021650

Substantially Equivalent

Quantel Medical

FDA 510(k) clearance K021650 for ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER, Substantially Equivalent on 2002-08-16. Applicant: Quantel Medical.

Clearance details

Applicant: Quantel Medical
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2002-05-20
Decision date: 2002-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hot Springs, AR, 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.