510(k) Report

Devices descending from K963123

1,324 later devices reach Arthrocare Arthroscopic Eletrosurgery System (Model 980) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+8K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+8K243854Contour Light (CL-100)Contour Research, LLC20261—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+8K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+8K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+8K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+8K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K250165PastelleWontech Co., Ltd.20250—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+8K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+8K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+8K250327OptaBlate Radiofrequency (RF) Generator SystemStryker Instruments20250—
+8K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+8K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+8K250125LMNT O2Xplr, Ltd.20250—
+8K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+8K243929Oligio XWontech Co., Ltd.20250—
+8K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+8K243097RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd.20240—
+8K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+8K231216PotenzaJeisys Medical, Inc.20244—
+8K231287PotenzaJeisys Medical, Inc.20241—
+8K241535Vybe RF IIShenB Co., Ltd.20240—
+8K241102Luna 4 plusForeo, Inc.20245—
+8K233123SilkroHironic Co., Ltd.20241—
+8K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+8K233344Regenalase Laser SystemIpg Medical20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K233224Epilaser ProEpilady 2000, LLC20240—
+8K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+8K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+8K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+8K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+8K231146AliTightAlic Iotech, LLC20230—
+8K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K230077LaserMENeauvia North America20232—
+8K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+8K223147myLEDmaskMyblend20234—
+8K223680Eneka ProTermosalud20230—
+8K222685NIRA Model 2Dermal Photonics Corp20230—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+8K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+8K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+8K222369PURE LaserEndymed Medical, Ltd.20220—
+8K212561MTX-C1Ilooda Co,., Ltd.20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+8K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K203013AGNESAgnes Medical Co., Ltd.20224—
+8K221083Smartlux MiniMedmix Co., Ltd.20222—
+8K212472AgeJetTriworks Group Srl20220—
+8K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+8K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+8K213534PHantom TrilogyResurgeonz, LLC20220—
+8K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+8K213814Viveve 2.0 SystemViveve, Inc.20220—
+8K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+8K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+8K210847UltraClear Fractional Laser SystemFa International, LP20210—
+8K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K211444CellFX SystemPulse Biosciences, Inc.20213—
+8K202780SectumNeauvia North America20211—
+8K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+8K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+8K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202988Tixel SystemNovoxel, Ltd.20211—
+8K201594Primelase ExcellenceHigh Technology Products S.L.U20202—