Cortex Laser System— 510(k) K150587

Substantially Equivalent

Cynosure, Inc. Dba Ellman

FDA 510(k) clearance K150587 for Cortex Laser System, Substantially Equivalent on 2015-07-21. Applicant: Cynosure, Inc. Dba Ellman.

Clearance details

Applicant: Cynosure, Inc. Dba Ellman
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2015-03-09
Decision date: 2015-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hicksville, NY, 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.