510(k) Report

Devices descending from K991935

1,492 later devices reach Epilight Hair Removal System, Photoderm HR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+4K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+4K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+4K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+4K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+4K071872VelashapeSyneron Medical, Ltd.2007127—
+4K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+4K071943Serenity Pro PSF SystemInolase 2002, Ltd.20071—
+4K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+4K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+4K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+4K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+4K061603SmoothshapesBiocellulase, Inc.200648—
+4K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+4K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+4K053611SmoothshapesBicellulase, Inc.200695—
+4K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+4K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+4K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+4K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K253765Vanish ProDdc Technologies, Inc.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—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K253035IPL Hair Removal Device (SYL001AZ, SYL002AZ)Gu'An Yeolight Smart Electronics Co., Ltd.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241527Pastelle ProWontech Co., Ltd.20253—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K243488Vmat ProTermosalud20250—
+5K241270BTL-754BTL Industries, Inc.20251—
+5K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+5K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro…Shenzhen Jianchao Intelligent Technology Co., Ltd.20243—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K240752Deka ToroEl.En S.P.A.20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+5K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+5K233237xeo+ FamilyCutera, Inc.20230—
+5K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd.20234—
+5K232236EchoQuanta System Spa20230—
+5K232056IPL Hair Removal Device, Model (s): PB1, PB2, PB3, PB4, TM002Dongguan Lide Electric Appliance Co., Ltd.20230—
+5K232274IPL hair removal deviceLumenessa Corp20230—
+5K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+5K231717IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016…Foshan Jindi Electric Appliance Co., Ltd.202311—
+5K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+5K230077LaserMENeauvia North America20232—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K222556BTL-785XBTL Industries, Inc.20235—
+5K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202311—
+5K221865BTL-094BTL Industries, Inc.20230—
+5K230122IPL Hair Removal Device, Model (s): UI04 SD, UI04 DGShenzhen Ulike Smart Electronics Co., Ltd.202317—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K223618IPL Hair Removal Device, Model (s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06…Shenzhen Ulike Smart Electronics Co., Ltd.20236—
+5K223524IPL Hair Removal, Model (s): SB01, SB01A, SB01B, SB01C, SN02, SN03Morlaser Shenzhen Co., Ltd.20230—
+5K210166Omnispec ED1000Medispec, Ltd.20230—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221643Hair Removal Device (Model: IPL-D26, IPL-D19)Shenzhen Desida Technology Co., Ltd.20220—
+5K222537IPL Hair Removal Device, Model (s): skn001,skn005,skn006,skn002,RoseSkinCo LumiShenzhen Ishine Technology Company Limited202211—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221553Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd.20221—