Tranberg CLS Laser Fiber— 510(k) K151569

Substantially Equivalent

Clinical Laserthermia Systems, AB

FDA 510(k) clearance K151569 for Tranberg CLS Laser Fiber, Substantially Equivalent on 2016-02-12. Applicant: Clinical Laserthermia Systems, AB.

Clearance details

Applicant: Clinical Laserthermia Systems, AB
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2015-06-10
Decision date: 2016-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lund, SE

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.