LASERMATIC COMBOLASER MODEL 5050— 510(k) K895279

Substantially Equivalent

Lasermatic OY

FDA 510(k) clearance K895279 for LASERMATIC COMBOLASER MODEL 5050, Substantially Equivalent on 1989-11-08. Applicant: Lasermatic OY.

Clearance details

Applicant: Lasermatic OY
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1989-08-24
Decision date: 1989-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View 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, 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.