510(k) Report

Devices descending from K022568

1,127 later devices reach Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+7K094049Stlase Diode LaserDental Photonics, Inc.201023—
+7K101415TheraclearTheravant Corporation20101—
+7K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+7K090094Zeltiq SystemZeltiq Aesthetics200932—
+7K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+8K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+8K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+8K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+8K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K252187Aura Glide (FC40)Aura Medical, LLC20250—
+8K251730LIA Console (542-7)Leadoptik, Inc.20250—
+8K252877SANDRO DualWontech Co., Ltd.20250—
+8K253123CuRAS hybridClassys, Inc.20250—
+8K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+8K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+8K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+8K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+8K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+8K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+8K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+8K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+8K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K250200InbellaBody SystemInbella Medical, Inc.20250—
+8K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+8K243929Oligio XWontech Co., Ltd.20250—
+8K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+8K231216PotenzaJeisys Medical, Inc.20244—
+8K231287PotenzaJeisys Medical, Inc.20241—
+8K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+8K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+8K241406LavieenWontech Co., Ltd.20242—
+8K233123SilkroHironic Co., Ltd.20241—
+8K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K234085LUNE™ PureHygieneEnamel Pure20241—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+8K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K230293TheraFace MaskTherabody, Inc.202316—
+8K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+8K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+8K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+8K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+8K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+8K221873NeoGen PSR SystemEnergist Limited20230—
+8K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+8K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+8K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+8K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+8K221407truSculpt iDCutera, Inc.20222—
+8K212472AgeJetTriworks Group Srl20220—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+8K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+8K211681EONDominion Aesthetic Technologies, Inc.20221—
+8K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+8K212155TheraFace LEDTheragun, Inc.202142—