510(k) Report

Devices descending from K963094

1,185 later devices reach Cynosure Photogenica LP Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K243488Vmat ProTermosalud20250—
+9K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+9K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+9K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K241102Luna 4 plusForeo, Inc.20245—
+9K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+9K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+9K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+9K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+9K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+9K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+9K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+9K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+9K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+9K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+9K223147myLEDmaskMyblend20234—
+9K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+9K221865BTL-094BTL Industries, Inc.20230—
+9K222685NIRA Model 2Dermal Photonics Corp20230—
+9K210166Omnispec ED1000Medispec, Ltd.20230—
+9K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+9K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+9K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+9K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+9K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+9K221083Smartlux MiniMedmix Co., Ltd.20222—
+9K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+9K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+9K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+9K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+9K213534PHantom TrilogyResurgeonz, LLC20220—
+9K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+9K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+9K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+9K211444CellFX SystemPulse Biosciences, Inc.20213—
+9K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+9K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+9K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+9K202988Tixel SystemNovoxel, Ltd.20211—
+9K193266MIINMedico USA, Inc.20210—
+9K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+9K193201BTL-785FBtl20208—
+9K201406PicowonWontech Co., Ltd.20200—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+9K200786Venus EpileveVenus Concept USA, Inc.20200—
+9K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+9K191065Venus VivaTMVenus Concept USA, Inc.20200—
+9K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+9K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+9K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+9K192331LaseMD LEO Laser SystemLutronic Global20190—
+9K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+9K183247dpl FacewareLed Technologies, Inc.201910—
+9K182173Joule SystemSciton, Inc20195—
+9K183118dpl SpotLiteLed Technologies, Inc.201922—
+9K180875Poly RejuvMedtek Skincare, LLC20180—
+9K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+9K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+9K173700PICOPLUS Laser SystemLutronic Corporation20187—
+9K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+9K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+9K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+9K1718212 Face / Face EvolutionHeat IN A Click201858—
+9K173199PicoSure WorkstationCynosure, Inc.20189—
+9K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+9K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+9K171648BM.IrisBluecore Co., Ltd.20172—
+9K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+9K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+9K170637sensiFirmEl Global Trade, Ltd.20173—
+9K171009LASEMD Laser SystemLutronic Corporation20178—
+9K162755PicocareWontech Co., Ltd.20179—
+9K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+9K170068Softcure 96Wellray Medical Laser, Inc.20170—
+9K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+9K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+9K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+9K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+9K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+9K160312Fraxis DuoIlooda Co,., Ltd.201614—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K161043Profound SystemSyneron Candela Corporation20160—
+9K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+9K153568InMode Plus SystemInmode MD, Ltd.201618—
+9K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+9K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+9K152856Helios IIILaseroptek Co., Ltd.20165—
+9K160480PicoSure WorkstationCynosure, Inc.201620—
+9K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+9K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+9K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+9K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+9K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+9K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+9K150326PicoWay Laser SystemCandela Corporation201568—
+9K143105Picosure WorkstationCynosure, Inc.201549—