DeviceClearance

IMAGE VASCULAR LASER— 510(k) K003046

Substantially Equivalent

Sciton, Inc

FDA 510(k) clearance K003046 for IMAGE VASCULAR LASER, Substantially Equivalent on 2000-11-24. Applicant: Sciton, Inc.

Clearance details

Applicant
Sciton, Inc
Product code
Code GEX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Palo Alto, CA, 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.