510(k) Report

Devices descending from K950239

1,329 later devices reach Sensimatic 500SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K093465Fusion SystemEclipsemed Global, Inc.20100—
+8K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+8K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+8K090221Reaction SystemViora, Ltd.200954—
+8K090525Loi SystemPalomar Medical Products, Inc.20099—
+8K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+8K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+8K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+8K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+8K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+8K082938EzlaseBiolase Technology, Inc.200850—
+8K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+8K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+8K081352Profile Multi-Platform SystemSciton, Inc2008112—
+8K081408Ellipse MultiflexEllipse A/S20087—
+8K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+8K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+8K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+8K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+8K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+8K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+8K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+8K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+8K072394Portrait Stand-OffRhytec Incorporated2007104—
+8K071872VelashapeSyneron Medical, Ltd.2007127—
+8K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+8K061603SmoothshapesBiocellulase, Inc.200648—
+8K053611SmoothshapesBicellulase, Inc.200695—
+8K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+8K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+8K041969Aurora DSSyneron Medical, Ltd.2004302—
+9K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+9K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+9K262364Ellian Enigma RF DeviceEllian Corp20260—
+9K253504Volnewmer™Classys, Inc.20260—
+9K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K252561BTL-754FFBTL Industries, Inc.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+9K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+9K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+9K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+9K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+9K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+9K251632Optimas MAX SystemInMode, Ltd.20251—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+9K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+9K250189AdvaTxAdvalight Aps20250—
+9K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+9K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+9K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+9K243488Vmat ProTermosalud20250—
+9K240311JETT Medical IICompex, Spol, S.R.O.20250—
+9K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+9K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K240897CellinewVIOL Co., Ltd.20240—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K231948MediyagMedicreations, LLC20240—
+9K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+9K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+9K233344Regenalase Laser SystemIpg Medical20240—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K234057NirvanaEl.En S.P.A.20240—
+9K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+9K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+9K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+9K240313Oligio XWontech Co., Ltd.20241—
+9K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+9K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+9K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+9K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+9K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+9K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+9K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+9K231054V-LaserWontech Co., Ltd.20231—
+9K230968VYBE RF Electrosurgical SystemShenB Co., Ltd.20231—
+9K221865BTL-094BTL Industries, Inc.20230—
+9K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+9K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+9K210166Omnispec ED1000Medispec, Ltd.20230—
+9K223540AvalancheLase FamilyFotona D.O.O.20230—
+9K221873NeoGen PSR SystemEnergist Limited20230—
+9K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+9K22079410PLTentech Co., Ltd.20220—
+9K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+9K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+9K213267Dynamis Pro FamilyFotona D.O.O.20222—
+9K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+9K212790XLase PlusBiotec Italia, Srl20220—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+9K213612Sylfirm XVIOL Co., Ltd.20221—