510(k) Report

Devices descending from K043586

13 later devices reach Laser Sys*Stim 540, Model ME 540 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113017Sys*Stim 240Mettler Electronics Corp.20129—
+1K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd.20052—
+2K223802accufitMettler Electronics Corporation20235—
+2K213655HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)Hilltek, LLC20231—
+2K123177Stimlase 2000 Low Level Laser Therapy SystemLaserstim, Inc.20130—
+2K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+3K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati20260—
+3K233926accufitMettler Electronics Corporation20244—
+3K150466ZX2 Laser SystemLzr7, Inc.20150—
+4K251594truFlexSyrma Johari Medtech Limited20250—
+4K241685SofWave SystemSofwave Medical, Ltd.20242—
+5K250146SofWave SystemSofwave Medical, Ltd.20251—
+6K251746Pure ImpactSofwave Medical, Ltd.20250—