510(k) Report

Devices descending from K962321

1,327 later devices reach Arthocare Arthroscopic Electrosurgery System Model 970 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K261570Picosure WorkstationCynosure, LLC20260—
+12K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+12K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+12K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+12K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+12K252369Boston Pico755Boston Aesthetics, Inc.20260—
+12K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+12K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+12K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+12K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+12K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+12K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+12K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+12K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+12K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+12K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+12K243957PicoalexWontech Co., Ltd.20250—
+12K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+12K243737Inbella RF SystemInbella Medical, Inc.20250—
+12K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+12K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+12K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+12K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+12K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+12K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+12K233766Geneo X ElitePollogen, Ltd.20240—
+12K234085LUNE™ PureHygieneEnamel Pure20241—
+12K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+12K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+12K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+12K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+12K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+12K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+12K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+12K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+12K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+12K223292TempSure SystemCynosure, LLC20220—
+12K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+12K220853PicoWay Laser SystemCandela Corporation20221—
+12K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+12K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+12K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+12K211681EONDominion Aesthetic Technologies, Inc.20221—
+12K212127PicocaremajestyWontech Co., Ltd.20226—
+12K213344BTL-899ABTL Industries, Inc.20222—
+12K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+12K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+12K212331BodySculpRohrer Aesthetics, LLC20211—
+12K201773PicohiHironic Co., Ltd.20215—
+12K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+12K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+12K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+12K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+12K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+12K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+12K173677InMode VLazeInmode MD, Ltd.20183—
+12K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+12K171111SculpsureCynosure, Inc.201710—
+12K163222Discovery Pico FamilyQuanta System Spa201630—
+12K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+12K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+13K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+13K260138LUNE PureHygieneEnamel Pure20260—
+13K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+13K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+13K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+13K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+13K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+13K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+13K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+13K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+13K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+13K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+13K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+13K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+13K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+13K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+13K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+13K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+13K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+13K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+13K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+13K240752Deka ToroEl.En S.P.A.20240—
+13K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+13K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+13K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+13K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+13K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+13K230467BTL-899FBTL Industries, Inc.20231—
+13K222226EONDominion Aesthetic Technologies, Inc.20230—
+13K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+13K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+13K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+13K192970SlimusHironic Co., Ltd.20200—
+13K171992SculpSureCynosure, Inc.20178—
+13K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+13K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+13K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+14K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—