510(k) Report

Devices descending from K023954

1,117 later devices reach Altus Medical Coolglide Laser Systems and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+7K202199BTL-899STBtl20216—
+7K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+7K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+7K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+7K190678TempSureCynosure, Inc.201914—
+7K190743Venus BlissVenus Concept USA, Inc.20194—
+7K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+7K182604New EraStep UP Skin Laser, LLC201801
+7K182365TempSure SystemCynosure, Inc.201815—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+7K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+7K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+7K171111SculpsureCynosure, Inc.201710—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K170116Thermi Injectable RF ElectrodesThermi20172—
+7K163190InMode RF SystemInmode MD, Ltd.20160—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+7K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+7K123889Acleara, TheraclearTheravant Corporation20130—
+7K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+7K111689StlaseDental Photonics, Inc.201222—
+8K254185Potenza PrimeJeisys Medical Incorporated20260—
+8K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+8K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+8K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+8K253803MILAN SystemLumenis Be, Ltd.20260—
+8K260138LUNE PureHygieneEnamel Pure20260—
+8K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+8K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+8K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+8K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+8K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+8K251254Ignite RF SystemInMode, Ltd.20260—
+8K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+8K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+8K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+8K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.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—
+8K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+8K252367InbellaMulti SystemInbella Medical, Inc.20250—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+8K250734OptiLUV DevicePollogen, Ltd.20250—
+8K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+8K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+8K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+8K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+8K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+8K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+8K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+8K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K241102Luna 4 plusForeo, Inc.20245—
+8K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)Weifang Dragonfly Electronics Technology Co., Ltd.20240—
+8K241642Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd.20240—
+8K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+8K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+8K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+8K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+8K233766Geneo X ElitePollogen, Ltd.20240—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+8K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+8K233642InMode RF SystemInMode, Ltd.20244—
+8K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—