510(k) Report

Devices descending from K013034

800 later devices reach Modification to: Thermacool Iia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+6K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+6K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+6K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+7K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K250165PastelleWontech Co., Ltd.20250—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+7K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K250189AdvaTxAdvalight Aps20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K231216PotenzaJeisys Medical, Inc.20244—
+7K231287PotenzaJeisys Medical, Inc.20241—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+7K233123SilkroHironic Co., Ltd.20241—
+7K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K240999Legend X Applicator VOPollogen, Ltd.20241—
+7K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K230837PlazMagikAgnes Medical Co., Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233147PiXel8-RFRohrer Aesthetics20230—
+7K232223PlaDuo SystemShenB Co., Ltd.20230—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K223110truSculpt iDCutera, Inc.20221—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K212472AgeJetTriworks Group Srl20220—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K213814Viveve 2.0 SystemViveve, Inc.20220—
+7K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+7K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+7K211107BTL-899 FPBTL Industries, Inc.20213—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+7K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+7K200241TempSure SystemCynosure, LLC202013—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+7K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+7K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+7K151655CO2RE SystemSyneron Medical, Ltd.20151—
+7K150724SculpSureCynosure, Inc.201521—
+7K150230SculpSureCynosure, Inc.201521—
+7K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+7K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+7K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+7K133945Cutera Picosecond Laser SystemCutera, Inc.201414—