510(k) Report

Devices descending from K885026

767 later devices reach Houva II Uvb through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K170068Softcure 96Wellray Medical Laser, Inc.20170—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+8K160368EVO platformQuanta System Spa201636—
+8K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+8K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+8K152012EVO platformQuanta System Spa201537—
+8K151629Guardian 1000Quanta System Spa20150—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+8K150051ExiliteBTL Industries, Inc.20150—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+8K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+8K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+8K140120EPIC 10Biolase, Inc.20141—
+8K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+8K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+8K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+8K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+8K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+8K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+8K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+8K121327Diolase 10SBiolase Technology, Inc.20132—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K121286EPIC 10Biolase Technology, Inc.201231—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+8K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+8K094049Stlase Diode LaserDental Photonics, Inc.201023—
+8K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+8K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+8K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+8K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+9K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K252187Aura Glide (FC40)Aura Medical, LLC20250—
+9K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+9K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+9K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+9K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+9K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+9K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+9K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+9K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+9K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+9K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+9K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+9K230293TheraFace MaskTherabody, Inc.202316—