510(k) Report

Devices descending from K013623

856 later devices reach Clearlight Phototheraphy System, Model CL 420 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180875Poly RejuvMedtek Skincare, LLC20180—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+5K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K1718212 Face / Face EvolutionHeat IN A Click201858—
+5K171702Exciplex308nmClarteis20175—
+5K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170068Softcure 96Wellray Medical Laser, Inc.20170—
+5K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131758Surgen UPollogen, Ltd.20135—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+5K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+5K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+5K082938EzlaseBiolase Technology, Inc.200850—
+5K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+5K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+6K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+6K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+6K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+6K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+6K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+6K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+6K252187Aura Glide (FC40)Aura Medical, LLC20250—
+6K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+6K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+6K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+6K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+6K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+6K250125LMNT O2Xplr, Ltd.20250—