510(k) Report

Devices descending from K180597

3 later devices reach AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+1K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+2K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—