510(k) Report

Devices descending from K062719

38 later devices reach Greenlight HPS Series Surgical Laser System & Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100746Fiber OneAmerican Medical Systems201021
+1K092735Greenlight XPS Laser SystemAmerican Medical Systems, Inc.200921
+1K090962Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TMQuanta System Spa20098—
+1K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922—
+2K240159InnoVoyce VYLOInnovoyce20240—
+2K202828Surgical Green Laser SystemRealton (Suzhou) Medical Technology Co., Ltd.20210—
+2K182036NeuroBlate SystemMonteris Medical,201811—
+2K172881NeuroBlate SystemMonteris Medical,201713—
+2K131081Cyber TM FamilyQuanta System Spa20132—
+2K120561Neuroblate SystemMonteris Medical, Inc.2013211
+2K120870Greenlight Moxy Fiber OpticAmerican Medical Systems201211
+2K102749Quanta Cyber TM 150WQuanta System Spa20107—
+3K231061NeuroBlate SystemMonteris Medical,20236—
+3K202601Single-use Sterile medical laser fiberRealton (Suzhou) Medical Technology Co., Ltd.20200—
+3K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+3K193375NeuroBlate SystemMonteris Medical,202010—
+3K173305NeuroBlate SystemMonteris Medical,201712—
+3K162334U.S. Laser Worx Patriot 1 family of lasersU.S. Laser Worx20171—
+3K170724NeuroBlate SystemMonteris Medical,201715—
+3K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+3K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+3K141983Neuroblate SystemMonteris Medical Corp.2014182
+3K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192
+3K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+4K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+4K251824Patriot DuoPatriot Laser, LLC20250—
+4K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+4K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+4K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+4K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+4K202041Opera EvoQuanta System Spa20200—
+4K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+4K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+5K262315NeuroBlate SystemMonteris Medical20260—
+5K260976NeuroBlate SystemMonteris Medical20261—
+5K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+5K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—
+5K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—