510(k) Report

Devices descending from K951033

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+8K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+8K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+8K131839DC 7Dc International, LLC20130—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K111689StlaseDental Photonics, Inc.201222—
+8K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+9K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+9K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+9K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+9K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+9K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+9K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+9K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+9K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+9K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+9K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+9K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+9K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+9K230167BACK 4Swims America Corp20230—
+9K230037BACK 3Swims America Corp20230—
+9K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+9K223805AgnesAgnes Medical Co., Ltd.20233—
+9K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+9K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+9K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+9K223110truSculpt iDCutera, Inc.20221—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K212891TempSure SystemCynosure, LLC20221—
+9K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+9K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+9K211107BTL-899 FPBTL Industries, Inc.20213—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K200693K2 MobileHulaser, Inc.20202—
+9K202041Opera EvoQuanta System Spa20200—
+9K193486Epic 980Biolase, Inc.20202—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+9K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+9K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+9K180044SIROLaser BlueDentsply Sirona201812—
+9K170709CURVE Laser SystemYolo Medical, Inc.20170—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K163128Epic ProBiolase, Inc.201716—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K160470SculpSureCynosure, Inc.201620—
+9K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+9K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—