510(k) Report

Devices descending from K962109

1,499 later devices reach SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+7K150230SculpSureCynosure, Inc.201521—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+7K150051ExiliteBTL Industries, Inc.20150—
+7K150027CYMAWhitecap Technologies, LLC20150—
+7K143109XP300BTL Industries, Inc.20150—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K141986Elux 810 LaserEquipmed North America, Inc.20150—
+7K140471Pro X Otc 5La Lumiere, LLC2015107—
+7K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+7K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K141904Viora V-TouchViora, Ltd.20140—
+7K140120EPIC 10Biolase, Inc.20141—
+7K140837Lucid LYBio-Med USA, Inc.20140—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+7K141583Shaser Skin Beauty Intense Pulsed Light System FamilyShaser, Inc.20142—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133774AtovenBio-Med USA, Inc.20146—
+7K140631Lumena FH Hair Removal SystemShaser, Inc.201495—
+7K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+7K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+7K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K131113Biophotas CellumaBiophotas, Inc.201455—
+7K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+7K130689Symphony RF GeneratorThermigen, Inc.201311—
+7K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+7K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+7K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+7K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+7K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+7K122579VelashapeSyneron Medical, Ltd.20124—
+7K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+7K110375Blueshine's Gold SeriesBlueshine Srl20124—
+7K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+7K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+7K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+7K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+7K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+7K101415TheraclearTheravant Corporation20101—
+7K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+7K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+7K083629SmoothshapesEleme Medical, Inc.200927—
+7K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+7K082938EzlaseBiolase Technology, Inc.200850—
+7K081570DPL Therapy SystemLed Technologies, LLC200811
+7K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+7K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+7K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+7K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+7K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+7K070690The Life VesselCottonwood Vessel Corporation20070—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+8K253504Volnewmer™Classys, Inc.20260—
+8K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+8K261473ChromixTermosalud S.L.20260—
+8K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+8K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2…Shenzhen Semlamp Intelligent Technology Co., Ltd.20260—
+8K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+8K243854Contour Light (CL-100)Contour Research, LLC20261—
+8K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+8K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+8K253304IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)Dongguan Lide Electric Appliance Co., Ltd.20250—
+8K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+8K252209IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)Foshan Jindi Electric Appliance Co., Ltd.20251—
+8K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.20250—
+8K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+8K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+8K251176IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20251—
+8K244060eCO2 3DLutronic Corporation20250—
+8K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+8K251984Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+8K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+8K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—