510(k) Report

Devices descending from K050047

109 later devices reach Cutera Optional Pulsed Light Hand Piece Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+1K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+1K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+1K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+1K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+2K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+2K192856MT OneM&T S.R.L.20202—
+2K180508Joule SystemSciton, Inc20183—
+2K172413MT ONEM&T S.R.L.20175—
+2K153229SuperbiumBios S.R.L.20162—
+2K152714Quanta ForteQuanta System Spa201513—
+2K133837Viora V-TotalViora, Ltd.201433—
+2K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+2K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+2K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+2K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+2K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+3K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K210847UltraClear Fractional Laser SystemFa International, LP20210—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K191942MT One DiamondM&T S.R.L.20191—
+3K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+3K142093V20 SystemViora, Ltd.201432—
+3K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+3K090399Trios SystemViora, Ltd.20090—
+3K083730IsolazAesthera Corporation20093—
+3K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+4K234057NirvanaEl.En S.P.A.20240—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+4K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200736Stardust MedI.T.S. Group S.R.L.20200—
+4K200616E>EyeCE-Swin20200—
+4K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+4K152611V20 systemViora, Ltd.20164—
+4K150035V10 systemViora, Ltd.201531—
+4K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+4K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+4K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+4K101415TheraclearTheravant Corporation20101—
+4K090094Zeltiq SystemZeltiq Aesthetics200932—
+5K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+5K181868SHINY RPL SystemIds, Ltd.20181—
+5K170637sensiFirmEl Global Trade, Ltd.20173—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+5K153568InMode Plus SystemInmode MD, Ltd.201618—
+5K123889Acleara, TheraclearTheravant Corporation20130—
+5K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+6K191855EmFace DeviceInmode MD, Ltd.20191—
+6K181095RF-ReliefEl Global Trade, Ltd.20181—
+6K172302InMode PLUS SystemInmode MD, Ltd.201713—
+6K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+6K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+6K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K250734OptiLUV DevicePollogen, Ltd.20250—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K183450EmBody SystemInmode MD, Ltd.20198—
+7K160470SculpSureCynosure, Inc.201620—
+7K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+7K150724SculpSureCynosure, Inc.201521—
+7K150230SculpSureCynosure, Inc.201521—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+8K211681EONDominion Aesthetic Technologies, Inc.20221—
+8K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+8K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+8K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+8K190743Venus BlissVenus Concept USA, Inc.20194—
+8K171111SculpsureCynosure, Inc.201710—
+8K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+9K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+9K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+9K230167BACK 4Swims America Corp20230—
+9K230037BACK 3Swims America Corp20230—
+9K222226EONDominion Aesthetic Technologies, Inc.20230—
+9K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+9K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+9K212331BodySculpRohrer Aesthetics, LLC20211—
+9K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+9K192970SlimusHironic Co., Ltd.20200—
+9K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+9K171992SculpSureCynosure, Inc.20178—
+9K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—