510(k) Report

Devices descending from K950239

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+9K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+9K140471Pro X Otc 5La Lumiere, LLC2015107—
+9K142910Legacy BXVenus Concept USA, Inc.201411—
+9K141904Viora V-TouchViora, Ltd.20140—
+9K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+9K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+9K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+9K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+9K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+9K133837Viora V-TotalViora, Ltd.201433—
+9K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+9K131113Biophotas CellumaBiophotas, Inc.201455—
+9K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+9K131758Surgen UPollogen, Ltd.20135—
+9K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+9K131839DC 7Dc International, LLC20130—
+9K130459Tria Fan SystemTria Beauty, Inc.20131—
+9K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+9K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+9K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+9K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+9K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+9K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+9K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+9K130465EPIC 10SBiolase Technology, Inc.20130—
+9K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+9K121286EPIC 10Biolase Technology, Inc.201231—
+9K122579VelashapeSyneron Medical, Ltd.20124—
+9K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+9K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+9K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+9K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+9K111689StlaseDental Photonics, Inc.201222—
+9K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+9K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+9K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+9K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+9K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+9K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+9K101321Ematrix CO2Syneron Medical, Ltd.20102—
+9K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+9K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+9K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+9K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+9K090094Zeltiq SystemZeltiq Aesthetics200932—
+9K083629SmoothshapesEleme Medical, Inc.200927—
+9K081570DPL Therapy SystemLed Technologies, LLC200811
+9K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+9K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+9K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+9K070690The Life VesselCottonwood Vessel Corporation20070—
+9K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+10K252723Dynamis Pro FamilyFotona D.O.O.20260—
+10K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261473ChromixTermosalud S.L.20260—
+10K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+10K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+10K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+10K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+10K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+10K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+10K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+10K243854Contour Light (CL-100)Contour Research, LLC20261—
+10K253342PICO-KSpeclipse, Inc.20251—
+10K251730LIA Console (542-7)Leadoptik, Inc.20250—
+10K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+10K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+10K253344Bellus-QSpeclipse, Inc.20250—
+10K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+10K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+10K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+10K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+10K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+10K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K250165PastelleWontech Co., Ltd.20250—
+10K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K251094Alma VeilWontech Co., Ltd.20250—
+10K250327OptaBlate Radiofrequency (RF) Generator SystemStryker Instruments20250—
+10K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+10K250125LMNT O2Xplr, Ltd.20250—
+10K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+10K243929Oligio XWontech Co., Ltd.20250—
+10K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+10K243097RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd.20240—
+10K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K241535Vybe RF IIShenB Co., Ltd.20240—
+10K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+10K241102Luna 4 plusForeo, Inc.20245—
+10K241600DermablateAsclepion Laser Technologies GmbH20240—
+10K233123SilkroHironic Co., Ltd.20241—
+10K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—