Global Med Systems Milesman Compact Laser— 510(k) K203804

Substantially Equivalent

Global Med Systems SL

FDA 510(k) clearance K203804 for Global Med Systems Milesman Compact Laser, Substantially Equivalent on 2021-02-23. Applicant: Global Med Systems SL.

Clearance details

Applicant
Global Med Systems SL
Product code
Code GEX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Leon, ES
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.