510(k) Report

Devices descending from K951033

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+8K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+8K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+8K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+8K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+8K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+8K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K243587PureLift GLOWXtreem Pulse, LLC20251—
+8K243330LYMA Laser PROLyma Life, Ltd.20250—
+8K250200InbellaBody SystemInbella Medical, Inc.20250—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K243097RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd.20240—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K231216PotenzaJeisys Medical, Inc.20244—
+8K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+8K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+8K231287PotenzaJeisys Medical, Inc.20241—
+8K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+8K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K241535Vybe RF IIShenB Co., Ltd.20240—
+8K241406LavieenWontech Co., Ltd.20242—
+8K233123SilkroHironic Co., Ltd.20241—
+8K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K203013AGNESAgnes Medical Co., Ltd.20224—
+8K221407truSculpt iDCutera, Inc.20222—
+8K212472AgeJetTriworks Group Srl20220—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+8K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+8K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K201773PicohiHironic Co., Ltd.20215—
+8K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+8K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+8K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+8K210948Omnilux CLEARGlobalmed Technologies202139—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+8K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+8K202199BTL-899STBtl20216—
+8K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K200241TempSure SystemCynosure, LLC202013—
+8K192430Epic 980Biolase, Inc.20195—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+8K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+8K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K170500SIROLaser Advance+Dentsply Sirona201721—
+8K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K150724SculpSureCynosure, Inc.201521—
+8K150230SculpSureCynosure, Inc.201521—
+8K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—