510(k) Report

Devices descending from K950019

1,568 later devices reach Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+8K160470SculpSureCynosure, Inc.201620—
+8K152731XP1100 RFBTL Industries, Inc.20160—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K151793InMode RF SystemInmode MD, Ltd.20161—
+8K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+8K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+8K142924Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyShaser, Inc.20150—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+8K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+8K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+8K132754Neogen PSR SystemEnergist, Ltd.20132—
+8K131839DC 7Dc International, LLC20130—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K111501I-Lipo SystemChromogenex Technologies Limited201215—
+8K111689StlaseDental Photonics, Inc.201222—
+8K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+8K090094Zeltiq SystemZeltiq Aesthetics200932—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+9K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+9K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP…Shenzhen Xiazhifeng Electronic Co., Ltd.20260—
+9K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.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—
+9K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+9K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+9K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+9K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+9K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K252877SANDRO DualWontech Co., Ltd.20250—
+9K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+9K253123CuRAS hybridClassys, Inc.20250—
+9K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+9K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+9K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+9K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+9K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K251914IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal…Miley Technology (Hebei) Co., Ltd.20250—
+9K251843Erchonia EVRLErchonia Corporation20250—
+9K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+9K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+9K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+9K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K250200InbellaBody SystemInbella Medical, Inc.20250—
+9K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+9K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+9K243929Oligio XWontech Co., Ltd.20250—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+9K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+9K241881IPL Hair Removal Device (JM-843, JM-865, JM-638)Shenzhen Junmei Technology Co., Ltd.20241—
+9K241406LavieenWontech Co., Ltd.20242—
+9K233123SilkroHironic Co., Ltd.20241—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—