510(k) Report

Devices descending from K040081

415 later devices reach Palomar Luxv Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K241656Eneka SelectifTermosalud20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K232236EchoQuanta System Spa20230—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+7K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+8K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+8K250734OptiLUV DevicePollogen, Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K213889PicoStarAsclepion Laser Technologies GmbH20220—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K201773PicohiHironic Co., Ltd.20215—
+8K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+8K183450EmBody SystemInmode MD, Ltd.20198—
+8K160470SculpSureCynosure, Inc.201620—
+8K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+8K150724SculpSureCynosure, Inc.201521—
+8K150230SculpSureCynosure, Inc.201521—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K211681EONDominion Aesthetic Technologies, Inc.20221—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K202503ChromeQuanta System Spa202012—
+9K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+9K190743Venus BlissVenus Concept USA, Inc.20194—
+9K171111SculpsureCynosure, Inc.201710—
+9K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+10K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+10K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+10K230167BACK 4Swims America Corp20230—
+10K230037BACK 3Swims America Corp20230—
+10K222226EONDominion Aesthetic Technologies, Inc.20230—
+10K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+10K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+10K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+10K213308Venus BlissMAXVenus Concept USA, Inc.20222—