510(k) Report

Devices descending from K040131

569 later devices reach Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+7K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+7K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K210084SilkroHironic Co., Ltd.20223—
+7K213889PicoStarAsclepion Laser Technologies GmbH20220—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+7K153566Magma SystemFormatk Systems, Ltd.20162—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K131839DC 7Dc International, LLC20130—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+8K251730LIA Console (542-7)Leadoptik, Inc.20250—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+8K250809Stellar M22Lumenis Be, Ltd.20250—
+8K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K242688Finiff SystemSkingrab Co., Ltd.20240—
+8K231216PotenzaJeisys Medical, Inc.20244—
+8K231287PotenzaJeisys Medical, Inc.20241—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K233123SilkroHironic Co., Ltd.20241—
+8K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K233604BTL-785SBTL Industries, Inc.20243—
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K212472AgeJetTriworks Group Srl20220—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K201773PicohiHironic Co., Ltd.20215—
+8K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K202503ChromeQuanta System Spa202012—
+8K202041Opera EvoQuanta System Spa20200—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—