510(k) Report

Devices descending from K030342

756 later devices reach Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+6K140120EPIC 10Biolase, Inc.20141—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+6K094049Stlase Diode LaserDental Photonics, Inc.201023—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+7K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+7K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+7K252369Boston Pico755Boston Aesthetics, Inc.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K252187Aura Glide (FC40)Aura Medical, LLC20250—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology 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—
+7K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K243957PicoalexWontech Co., Ltd.20250—
+7K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+7K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+7K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+7K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+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—
+7K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+7K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+7K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+7K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+7K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+7K230077LaserMENeauvia North America20232—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K230293TheraFace MaskTherabody, Inc.202316—
+7K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+7K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+7K220853PicoWay Laser SystemCandela Corporation20221—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—