510(k) Report

Devices descending from K033946

737 later devices reach Lovely System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150035V10 systemViora, Ltd.201531—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K150051ExiliteBTL Industries, Inc.20150—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140120EPIC 10Biolase, Inc.20141—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+5K121286EPIC 10Biolase Technology, Inc.201231—
+5K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+5K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+5K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+5K094049Stlase Diode LaserDental Photonics, Inc.201023—
+5K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+5K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment 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—
+6K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+6K252187Aura Glide (FC40)Aura Medical, LLC20250—
+6K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec 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—
+6K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K250281Deka LotusEl.En S.P.A.20250—
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+6K241270BTL-754BTL Industries, Inc.20251—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+6K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+6K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+6K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K241656Eneka SelectifTermosalud20241—
+6K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K232236EchoQuanta System Spa20230—
+6K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230077LaserMENeauvia North America20232—
+6K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+6K230293TheraFace MaskTherabody, Inc.202316—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—