510(k) Report

Devices descending from K800617

1,325 later devices reach Hyfrecator, #733 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K252369Boston Pico755Boston Aesthetics, Inc.20260—
+11K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+11K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+11K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+11K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+11K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+11K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+11K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+11K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+11K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+11K243957PicoalexWontech Co., Ltd.20250—
+11K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+11K243737Inbella RF SystemInbella Medical, Inc.20250—
+11K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+11K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+11K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+11K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+11K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+11K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+11K233766Geneo X ElitePollogen, Ltd.20240—
+11K234085LUNE™ PureHygieneEnamel Pure20241—
+11K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+11K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+11K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+11K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+11K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+11K223292TempSure SystemCynosure, LLC20220—
+11K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+11K220853PicoWay Laser SystemCandela Corporation20221—
+11K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+11K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K211681EONDominion Aesthetic Technologies, Inc.20221—
+11K212127PicocaremajestyWontech Co., Ltd.20226—
+11K213344BTL-899ABTL Industries, Inc.20222—
+11K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+11K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+11K212331BodySculpRohrer Aesthetics, LLC20211—
+11K201773PicohiHironic Co., Ltd.20215—
+11K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+11K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+11K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+11K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+11K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+11K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+11K173677InMode VLazeInmode MD, Ltd.20183—
+11K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+11K171111SculpsureCynosure, Inc.201710—
+11K163222Discovery Pico FamilyQuanta System Spa201630—
+11K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+11K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+11K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+11K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+12K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+12K260138LUNE PureHygieneEnamel Pure20260—
+12K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+12K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+12K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+12K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+12K253007Laser 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—
+12K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+12K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+12K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+12K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+12K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+12K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+12K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+12K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+12K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+12K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+12K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+12K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+12K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+12K240752Deka ToroEl.En S.P.A.20240—
+12K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+12K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+12K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+12K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+12K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+12K230467BTL-899FBTL Industries, Inc.20231—
+12K222226EONDominion Aesthetic Technologies, Inc.20230—
+12K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+12K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+12K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+12K192970SlimusHironic Co., Ltd.20200—
+12K171992SculpSureCynosure, Inc.20178—
+12K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+12K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+12K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+13K261701Hemolase 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—
+13K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+13K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+13K231971Deka Physiq 360El.En S.P.A.20230—