DeviceClearance

LASERCOMP MODEL: 10 STAR 10— 510(k) K885170

Substantially Equivalent

Laser-West

FDA 510(k) clearance K885170 for LASERCOMP MODEL: 10 STAR 10, Substantially Equivalent on 1989-06-05. Applicant: Laser-West.

Clearance details

Applicant
Laser-West
Product code
Code GEX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, 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.