510(k) Report

Devices descending from K951033

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K190678TempSureCynosure, Inc.201914—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K190743Venus BlissVenus Concept USA, Inc.20194—
+7K190443MMSphereGalactic Beauty, LLC201942—
+7K183450EmBody SystemInmode MD, Ltd.20198—
+7K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+7K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K182669Youlaser CO2Quanta System Spa20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+7K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+7K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+7K171262TempSureCynosure, Inc.201716—
+7K170984LG Beauty Led MaskLg Electronics201793—
+7K172004truSculptCutera, Inc.20173—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+7K152731XP1100 RFBTL Industries, Inc.20160—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K160691Acne Light Therapy WandZuko, Inc.201650—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K151629Guardian 1000Quanta System Spa20150—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K150027CYMAWhitecap Technologies, LLC20150—
+7K140120EPIC 10Biolase, Inc.20141—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K132754Neogen PSR SystemEnergist, Ltd.20132—
+7K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+7K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K121286EPIC 10Biolase Technology, Inc.201231—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K111501I-Lipo SystemChromogenex Technologies Limited201215—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+7K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+7K094049Stlase Diode LaserDental Photonics, Inc.201023—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+8K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+8K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+8K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+8K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+8K253123CuRAS hybridClassys, Inc.20250—
+8K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+8K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+8K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+8K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+8K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+8K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+8K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+8K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K244060eCO2 3DLutronic Corporation20250—