510(k) Report

Devices descending from K950239

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+10K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+10K172004truSculptCutera, Inc.20173—
+10K170637sensiFirmEl Global Trade, Ltd.20173—
+10K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+10K170500SIROLaser Advance+Dentsply Sirona201721—
+10K170068Softcure 96Wellray Medical Laser, Inc.20170—
+10K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+10K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+10K163128Epic ProBiolase, Inc.201716—
+10K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+10K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+10K162781Magma SparkFormatk Systems, Ltd.20160—
+10K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+10K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+10K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+10K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+10K152731XP1100 RFBTL Industries, Inc.20160—
+10K153568InMode Plus SystemInmode MD, Ltd.201618—
+10K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+10K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+10K153717Venus Versa SystemVenus Concept, Ltd.20161—
+10K152611V20 systemViora, Ltd.20164—
+10K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+10K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+10K151655CO2RE SystemSyneron Medical, Ltd.20151—
+10K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+10K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+10K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+10K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+10K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+10K141868Tria FanpTria Beauty, Inc.20140—
+10K142093V20 SystemViora, Ltd.201432—
+10K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+10K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+10K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+10K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+10K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+10K133364Picosure WorkstationCynosure, Inc.201451—
+10K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+10K132754Neogen PSR SystemEnergist, Ltd.20132—
+10K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+10K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+10K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+10K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+10K121346Picosure WorkstationCynosure, Inc.201287—
+10K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+10K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+10K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+10K111501I-Lipo SystemChromogenex Technologies Limited201215—
+10K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+11K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+11K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+11K254185Potenza PrimeJeisys Medical Incorporated20260—
+11K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+11K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+11K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+11K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+11K253803MILAN SystemLumenis Be, Ltd.20260—
+11K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+11K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+11K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+11K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+11K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+11K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+11K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+11K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+11K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+11K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+11K251254Ignite RF SystemInMode, Ltd.20260—
+11K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+11K252187Aura Glide (FC40)Aura Medical, LLC20250—
+11K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+11K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+11K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+11K252367InbellaMulti SystemInbella Medical, Inc.20250—
+11K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+11K251334New Doublo 2.0Hironic Co., Ltd.20250—
+11K242859VEGAIbramed Equipamentos Médicos20250—
+11K251843Erchonia EVRLErchonia Corporation20250—
+11K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+11K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+11K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+11K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+11K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+11K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+11K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+11K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+11K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+11K250809Stellar M22Lumenis Be, Ltd.20250—
+11K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+11K250200InbellaBody SystemInbella Medical, Inc.20250—
+11K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+11K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+11K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+11K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+11K243139Reverso Pro SystemIndiba S. A. U.20250—
+11K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+11K242598DEFINE System (AG612444A)InMode, Ltd.20240—