510(k) Report

Devices descending from K921884

1,365 later devices reach FORCE 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+8K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+8K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+8K090094Zeltiq SystemZeltiq Aesthetics200932—
+8K083629SmoothshapesEleme Medical, Inc.200927—
+8K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+8K082938EzlaseBiolase Technology, Inc.200850—
+8K081570DPL Therapy SystemLed Technologies, LLC200811
+8K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+8K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+8K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+8K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+8K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+8K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+8K070690The Life VesselCottonwood Vessel Corporation20070—
+8K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+9K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+9K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261964Echolaser X4Elesta S.P.A20260—
+9K261473ChromixTermosalud S.L.20260—
+9K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+9K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+9K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+9K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+9K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+9K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+9K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+9K243854Contour Light (CL-100)Contour Research, LLC20261—
+9K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+9K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+9K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+9K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+9K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+9K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K250165PastelleWontech Co., Ltd.20250—
+9K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K250327OptaBlate Radiofrequency (RF) Generator SystemStryker Instruments20250—
+9K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+9K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+9K250125LMNT O2Xplr, Ltd.20250—
+9K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+9K243929Oligio XWontech Co., Ltd.20250—
+9K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+9K243097RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd.20240—
+9K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241535Vybe RF IIShenB Co., Ltd.20240—
+9K241102Luna 4 plusForeo, Inc.20245—
+9K233123SilkroHironic Co., Ltd.20241—
+9K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+9K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+9K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233224Epilaser ProEpilady 2000, LLC20240—
+9K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+9K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+9K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+9K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+9K231146AliTightAlic Iotech, LLC20230—
+9K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+9K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K230077LaserMENeauvia North America20232—
+9K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+9K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+9K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+9K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+9K223147myLEDmaskMyblend20234—
+9K223680Eneka ProTermosalud20230—
+9K222685NIRA Model 2Dermal Photonics Corp20230—
+9K222701MANTA LaserSqualus Med, Ltd.20222—
+9K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+9K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K222369PURE LaserEndymed Medical, Ltd.20220—
+9K212561MTX-C1Ilooda Co,., Ltd.20220—
+9K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+9K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+9K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+9K203013AGNESAgnes Medical Co., Ltd.20224—