510(k) Report

Devices descending from K060304

42 later devices reach Photex Diode Laser Series, Models 980, 810 and 940 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+1K092197PHOTEX30 Diode Laser Series: 980, 810, 940Biotex, Inc.20092—
+1K071815Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc.20070—
+1K071328Visualase Thermal Therapy SystemBiotex, Inc.2007261
+1K062363BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NMB&W Tek, Inc.200711—
+2K142216Tranberg CLS Thermal Therapy SystemClinical Laserthermia Systems, AB20151—
+2K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922—
+2K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+2K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+2K081656Visualase Thermal Therapy SystemBiotex, Inc.2008101
+3K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+3K201687Avenda Health Treatment SystemAvenda Health, Inc.20200—
+3K181859Visualase Thermal Therapy SystemMedtronic Navigation, Inc.201991
+3K182036NeuroBlate SystemMonteris Medical,201811—
+3K172881NeuroBlate SystemMonteris Medical,201713—
+3K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+3K120561Neuroblate SystemMonteris Medical, Inc.2013211
+3K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+3K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+4K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+4K231061NeuroBlate SystemMonteris Medical,20236—
+4K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB20227—
+4K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+4K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+4K193375NeuroBlate SystemMonteris Medical,202010—
+4K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+4K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+4K173305NeuroBlate SystemMonteris Medical,201712—
+4K170724NeuroBlate SystemMonteris Medical,201715—
+4K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+4K141983Neuroblate SystemMonteris Medical Corp.2014182
+4K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192
+4K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+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—
+5K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+5K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+5K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+5K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+6K262315NeuroBlate SystemMonteris Medical20260—
+6K260976NeuroBlate SystemMonteris Medical20261—