510(k) Report

Devices descending from K954031

751 later devices reach Compu-Blend Epilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+7K250189AdvaTxAdvalight Aps20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K240897CellinewVIOL Co., Ltd.20240—
+7K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K240313Oligio XWontech Co., Ltd.20241—
+7K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+7K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+7K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+7K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+7K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+7K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+7K193201BTL-785FBtl20208—
+7K200104OxylightRaja Trading Company, Inc.202024—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K192224BTL-899Btl20198—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+7K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K172004truSculptCutera, Inc.20173—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+7K152731XP1100 RFBTL Industries, Inc.20160—
+7K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K151629Guardian 1000Quanta System Spa20150—
+7K151655CO2RE SystemSyneron Medical, Ltd.20151—
+7K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+7K150724SculpSureCynosure, Inc.201521—
+7K150230SculpSureCynosure, Inc.201521—
+7K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+7K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+7K142910Legacy BXVenus Concept USA, Inc.201411—
+7K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+7K140120EPIC 10Biolase, Inc.20141—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+7K133364Picosure WorkstationCynosure, Inc.201451—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+7K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+7K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+7K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+7K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+7K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+7K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+7K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K122966XP200Btl Industries, Ltd.20131—
+7K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K121346Picosure WorkstationCynosure, Inc.201287—
+7K121286EPIC 10Biolase Technology, Inc.201231—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—