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
+4K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+4K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+4K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+4K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+5K261473ChromixTermosalud S.L.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K243854Contour Light (CL-100)Contour Research, LLC20261—
+5K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251843Erchonia EVRLErchonia Corporation20250—
+5K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+5K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+5K250165PastelleWontech Co., Ltd.20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+5K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+5K241102Luna 4 plusForeo, Inc.20245—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+5K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+5K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+5K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K223147myLEDmaskMyblend20234—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+5K223680Eneka ProTermosalud20230—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K210948Omnilux CLEARGlobalmed Technologies202139—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K183247dpl FacewareLed Technologies, Inc.201910—
+5K183118dpl SpotLiteLed Technologies, Inc.201922—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—