510(k) Report

Devices descending from K951033

1,265 later devices reach Andela Dynamic Cooling Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180406Ellipse YdunEllipse A/S20180—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K171648BM.IrisBluecore Co., Ltd.20172—
+6K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K171009LASEMD Laser SystemLutronic Corporation20178—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K170068Softcure 96Wellray Medical Laser, Inc.20170—
+6K163415SlimShape SystemSyneron Medical, Ltd.201714—
+6K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+6K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+6K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+6K162512truSculptCutera, Inc.20165—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+6K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+6K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+6K143554Venus Legacy CXVenus Concept, Ltd.201517—
+6K143559XP1000 RFBTL Industries, Inc.20157—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+6K142910Legacy BXVenus Concept USA, Inc.201411—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K141904Viora V-TouchViora, Ltd.20140—
+6K140837Lucid LYBio-Med USA, Inc.20140—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+6K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+6K131758Surgen UPollogen, Ltd.20135—
+6K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+6K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+6K123573Youlaser CO2 LaserQuanta System Spa201319—
+6K123889Acleara, TheraclearTheravant Corporation20130—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K122579VelashapeSyneron Medical, Ltd.20124—
+6K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+6K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+6K110375Blueshine's Gold SeriesBlueshine Srl20124—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+6K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+6K091115ECO2 Laser SystemLutronic Corporation200927—
+6K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+6K090094Zeltiq SystemZeltiq Aesthetics200932—
+6K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+6K083629SmoothshapesEleme Medical, Inc.200927—
+6K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+6K082938EzlaseBiolase Technology, Inc.200850—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+6K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+6K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+6K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+6K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+6K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+7K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K262364Ellian Enigma RF DeviceEllian Corp20260—
+7K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+7K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+7K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—