510(k) Report

Devices descending from K100415

10 later devices reach Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.20183—
+1K141658Light ScalpelLightscalpel, LLC20142—
+1K132661LightscalpelLightscalpel, LLC20143—
+1K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+2K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+2K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+2K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+2K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+2K173827LightScalpelLightscalpel, LLC20180—
+3K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—