DeviceClearance

KAVO K.E.Y. LASER 1242— 510(k) K000805

Substantially Equivalent

Kavo America

FDA 510(k) clearance K000805 for KAVO K.E.Y. LASER 1242, Substantially Equivalent on 2000-05-04. Applicant: Kavo America.

Clearance details

Applicant
Kavo America
Product code
Code GEX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Zurich, IL, US
Download summary PDFView on FDA.gov ↗

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, through . 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.