510(k) Report

Devices descending from K971737

1,000 later devices reach Cynosure Photogenica Lpir Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K093465Fusion SystemEclipsemed Global, Inc.20100—
+6K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+6K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K080374Biosyag Medical SystemBios S.R.L.20082—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+6K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+6K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+6K070392Mosaic Laser SystemLutronic Corporation20078—
+6K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+6K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+6K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+6K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+6K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+7K261975Braun Aura 7 (6041)CyDen Limited20260—
+7K261977Braun Aura 9 (6042)Cyden Limited20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K253765Vanish ProDdc Technologies, Inc.20260—
+7K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+7K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07…Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+7K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+7K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K252877SANDRO DualWontech Co., Ltd.20250—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co., Ltd.20250—
+7K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250171IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd.20251—
+7K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+7K241527Pastelle ProWontech Co., Ltd.20253—
+7K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+7K243362SmoothSkin Pure Switch (SSC1)Cyden Limited20241—
+7K231948MediyagMedicreations, LLC20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240752Deka ToroEl.En S.P.A.20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+7K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+7K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+7K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+7K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K22079410PLTentech Co., Ltd.20220—
+7K221761SoleaConvergent Dental, Inc.202201
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K213428EdgeProBiolase, Inc.20210—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+7K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.20210—
+7K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K200616E>EyeCE-Swin20200—
+7K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—