510(k) Report

Devices descending from K951033

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K053324Chromolite SystemChromogenex Plc200631—
+4K052778Thermage Thermacool Skin MarketingThermage, Inc.2005130—
+4K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+4K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+4K050452Aurora SR and Sra ApplicatorSyneron Medical, Ltd.2005301—
+4K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+4K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+4K041969Aurora DSSyneron Medical, Ltd.2004302—
+4K032514AC Applicator, Aurora ACSyneron Medical, Ltd.20041—
+4K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+4K031671Polaris WRSyneron Medical, Ltd.2003678—
+4K030186Polris LVSyneron Medical, Ltd.2003680—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K253765Vanish ProDdc Technologies, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K250852CoolfaseAsterasys Co., Ltd.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K251327XERFLutronic Corporation202501
+5K250165PastelleWontech Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+5K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K242241SunnyShenB Co., Ltd.20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241527Pastelle ProWontech Co., Ltd.20253—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K241270BTL-754BTL Industries, Inc.20251—
+5K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+5K242688Finiff SystemSkingrab Co., Ltd.20240—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+5K242132FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda20240—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K240070Profound MatrixCandela Corporation20240—
+5K240752Deka ToroEl.En S.P.A.20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240248Volnewmer™Classys, Inc.20241—
+5K233849BTL-499BTL Industries, Inc.20240—
+5K233604BTL-785SBTL Industries, Inc.20243—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+5K23299210THERMATentech, Inc.20230—
+5K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+5K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K230663DensityJeisys Medical, Inc.20232—
+5K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+5K230077LaserMENeauvia North America20232—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221989The OligioWontech Co., Ltd.20222—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+5K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+5K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+5K210077MED RF 4000F Care Systems USA, LLC20211—
+5K211217Profound MatrixCandela Corporation20210—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K200472Viveve SystemViveve Medical, Inc.20202—
+5K192275invisa-RED ELITEIR Technology, LLC20201—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+5K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193426Elite iQCynosure, LLC20201—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—