510(k) Report

Devices descending from K010316

520 later devices reach Cooltouch Varia ND:Yag Laser System; Cooltouch Varia-II ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K232236EchoQuanta System Spa20230—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K210084SilkroHironic Co., Ltd.20223—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K202172StarWalkerFotona D.O.O.20203—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K180406Ellipse YdunEllipse A/S20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K160368EVO platformQuanta System Spa201636—
+8K152012EVO platformQuanta System Spa201537—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K131839DC 7Dc International, LLC20130—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K233123SilkroHironic Co., Ltd.20241—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—