510(k) Report

Devices descending from K984552

1,174 later devices reach Cool-Tip RF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131758Surgen UPollogen, Ltd.20135—
+6K130459Tria Fan SystemTria Beauty, Inc.20131—
+6K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+6K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+6K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+6K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K122579VelashapeSyneron Medical, Ltd.20124—
+6K110375Blueshine's Gold SeriesBlueshine Srl20124—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+6K101321Ematrix CO2Syneron Medical, Ltd.20102—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+6K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K090094Zeltiq SystemZeltiq Aesthetics200932—
+6K083629SmoothshapesEleme Medical, Inc.200927—
+6K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+6K082938EzlaseBiolase Technology, Inc.200850—
+6K081570DPL Therapy SystemLed Technologies, LLC200811
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+6K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+6K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+6K070690The Life VesselCottonwood Vessel Corporation20070—
+6K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+7K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261473ChromixTermosalud S.L.20260—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+7K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+7K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K243854Contour Light (CL-100)Contour Research, LLC20261—
+7K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+7K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+7K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+7K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+7K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K250165PastelleWontech 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—
+7K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+7K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K250125LMNT O2Xplr, Ltd.20250—
+7K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+7K243929Oligio XWontech Co., Ltd.20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K243097RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd.20240—
+7K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+7K231216PotenzaJeisys Medical, Inc.20244—
+7K231287PotenzaJeisys Medical, Inc.20241—
+7K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.20240—
+7K241535Vybe RF IIShenB Co., Ltd.20240—
+7K241825Microwave Ablation AntennasCanyon Medical, Inc.20240—
+7K241102Luna 4 plusForeo, Inc.20245—
+7K233123SilkroHironic Co., Ltd.20241—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+7K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.20240—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—
+7K240999Legend X Applicator VOPollogen, Ltd.20241—
+7K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+7K230837PlazMagikAgnes Medical Co., Ltd.20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.20240—
+7K233224Epilaser ProEpilady 2000, LLC20240—
+7K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+7K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+7K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd.20231—
+7K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd.20231—
+7K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+7K233147PiXel8-RFRohrer Aesthetics20230—