510(k) Report

Devices descending from K082809

12 later devices reach Acupulse 30 and 40 Carbon Dioxide Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101904Smartxide 50 HS/MSEl.En Electronic Engineering Spa20110—
+1K100415Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis2010101
+2K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.20183—
+2K141658Light ScalpelLightscalpel, LLC20142—
+2K132661LightscalpelLightscalpel, LLC20143—
+2K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+3K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+3K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+3K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+3K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+3K173827LightScalpelLightscalpel, LLC20180—
+4K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—