510(k) Report

Devices descending from K910422

1,503 later devices reach Model RD-1200 Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+8K143554Venus Legacy CXVenus Concept, Ltd.201517—
+8K150724SculpSureCynosure, Inc.201521—
+8K143559XP1000 RFBTL Industries, Inc.20157—
+8K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+8K150230SculpSureCynosure, Inc.201521—
+8K150035V10 systemViora, Ltd.201531—
+8K150326PicoWay Laser SystemCandela Corporation201568—
+8K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+8K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+8K150051ExiliteBTL Industries, Inc.20150—
+8K150027CYMAWhitecap Technologies, LLC20150—
+8K143109XP300BTL Industries, Inc.20150—
+8K143105Picosure WorkstationCynosure, Inc.201549—
+8K141986Elux 810 LaserEquipmed North America, Inc.20150—
+8K140471Pro X Otc 5La Lumiere, LLC2015107—
+8K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+8K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+8K142372Pico Way Laser SystemCandela Corpation201470—
+8K141904Viora V-TouchViora, Ltd.20140—
+8K140120EPIC 10Biolase, Inc.20141—
+8K140837Lucid LYBio-Med USA, Inc.20140—
+8K140719Picosure WorkstationCynosure, Inc.201450—
+8K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+8K141583Shaser Skin Beauty Intense Pulsed Light System FamilyShaser, Inc.20142—
+8K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+8K133774AtovenBio-Med USA, Inc.20146—
+8K140631Lumena FH Hair Removal SystemShaser, Inc.201495—
+8K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+8K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+8K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K131113Biophotas CellumaBiophotas, Inc.201455—
+8K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+8K130689Symphony RF GeneratorThermigen, Inc.201311—
+8K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+8K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+8K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+8K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+8K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+8K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+8K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+8K121327Diolase 10SBiolase Technology, Inc.20132—
+8K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+8K122579VelashapeSyneron Medical, Ltd.20124—
+8K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+8K110375Blueshine's Gold SeriesBlueshine Srl20124—
+8K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+8K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+8K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+8K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+8K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+8K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+8K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+8K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+8K101415TheraclearTheravant Corporation20101—
+8K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+8K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+8K083629SmoothshapesEleme Medical, Inc.200927—
+8K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+8K082938EzlaseBiolase Technology, Inc.200850—
+8K081570DPL Therapy SystemLed Technologies, LLC200811
+8K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+8K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+8K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+8K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+8K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+8K070690The Life VesselCottonwood Vessel Corporation20070—
+9K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+9K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+9K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+9K253504Volnewmer™Classys, Inc.20260—
+9K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+9K261473ChromixTermosalud S.L.20260—
+9K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+9K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K260518IPL 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—
+9K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+9K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+9K243854Contour Light (CL-100)Contour Research, LLC20261—
+9K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+9K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+9K253304IPL 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—
+9K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+9K252209IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)Foshan Jindi Electric Appliance Co., Ltd.20251—
+9K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.20250—
+9K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+9K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+9K251176IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20251—
+9K244060eCO2 3DLutronic Corporation20250—
+9K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+9K251984Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…Shenzhen Ulike Smart Electronics Co., Ltd.20250—