MULTILASER SYSTEM— 510(k) K123777

Substantially Equivalent

Ultralight Laser Technologies, LLC

FDA 510(k) clearance K123777 for MULTILASER SYSTEM, Substantially Equivalent on 2013-04-11. Applicant: Ultralight Laser Technologies, LLC.

Clearance details

Applicant: Ultralight Laser Technologies, LLC
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2012-12-10
Decision date: 2013-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, AL, 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.