ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories— 510(k) K233301

Substantially Equivalent

Lumenis Be, Ltd.

FDA 510(k) clearance K233301 for ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories, Substantially Equivalent on 2023-12-01. Applicant: Lumenis Be, Ltd..

Clearance details

Applicant: Lumenis Be, Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2023-09-29
Decision date: 2023-12-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Yokneam Ilit, IL

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.