510(k) Report

Devices descending from K051214

476 later devices reach Aluma Skin Renewal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K240248Volnewmer™Classys, Inc.20241—
+4K233849BTL-499BTL Industries, Inc.20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K233604BTL-785SBTL Industries, Inc.20243—
+4K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K23299210THERMATentech, Inc.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K231146AliTightAlic Iotech, LLC20230—
+4K230663DensityJeisys Medical, Inc.20232—
+4K22079410PLTentech Co., Ltd.20220—
+4K221989The OligioWontech Co., Ltd.20222—
+4K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+4K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+4K200616E>EyeCE-Swin20200—
+4K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K191065Venus VivaTMVenus Concept USA, Inc.20200—
+4K193656SkyPulseFotona D.O.O.202011—
+4K192545PotenzaJeisys Medical Incorporated202020—
+4K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+4K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+4K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+4K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+4K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+4K173503Pollogen Legend SystemPollogen, Ltd.20183—
+4K180508Joule SystemSciton, Inc20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172413MT ONEM&T S.R.L.20175—
+4K172096FraxisIlooda Co,., Ltd.20172—
+4K170325Secret RFIlooda Co,., Ltd.201710—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K163415SlimShape SystemSyneron Medical, Ltd.201714—
+4K162512truSculptCutera, Inc.20165—
+4K162781Magma SparkFormatk Systems, Ltd.20160—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+4K152714Quanta ForteQuanta System Spa201513—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K143559XP1000 RFBTL Industries, Inc.20157—
+4K143109XP300BTL Industries, Inc.20150—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K130689Symphony RF GeneratorThermigen, Inc.201311—
+4K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+5K253504Volnewmer™Classys, Inc.20260—
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K253750BTL-785NEHBTL Industries, Inc.20260—
+5K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K250809Stellar M22Lumenis Be, Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+5K243139Reverso Pro SystemIndiba S. A. U.20250—
+5K242532BTL-785BNF-EBTL Industries, Inc.20241—
+5K240897CellinewVIOL Co., Ltd.20240—
+5K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K240313Oligio XWontech Co., Ltd.20241—
+5K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+5K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K222790F65 Laser SystemLumenis Be, Ltd.20233—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+5K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K210084SilkroHironic Co., Ltd.20223—