KEY LASER III 1243 US WITH DETECT— 510(k) K073074

Substantially Equivalent

Kavo America

FDA 510(k) clearance K073074 for KEY LASER III 1243 US WITH DETECT, Substantially Equivalent on 2008-07-10. Applicant: Kavo America.

Clearance details

Applicant: Kavo America
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2007-10-31
Decision date: 2008-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Deer Field, IL, 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.