510(k) Report

Devices descending from K000079

801 later devices reach Nikopad Electrosurgical Grounding Pad, Model 4777M through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+10K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+10K160368EVO platformQuanta System Spa201636—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152012EVO platformQuanta System Spa201537—
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+10K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+11K261570Picosure WorkstationCynosure, LLC20260—
+11K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+11K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+11K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+11K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+11K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+11K252369Boston Pico755Boston Aesthetics, Inc.20260—
+11K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+11K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+11K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+11K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+11K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+11K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+11K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+11K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+11K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+11K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+11K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+11K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+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—
+11K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.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—
+11K240780InMode RF SystemInMode, Ltd.20243—
+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—
+11K234085LUNE™ PureHygieneEnamel Pure20241—
+11K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+11K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K231971Deka Physiq 360El.En S.P.A.20230—
+11K230467BTL-899FBTL Industries, Inc.20231—
+11K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K220853PicoWay Laser SystemCandela Corporation20221—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K212127PicocaremajestyWontech Co., Ltd.20226—
+11K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+11K201773PicohiHironic Co., Ltd.20215—
+11K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+11K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+11K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+11K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+11K182741SculpSureCynosure20195—
+11K173677InMode VLazeInmode MD, Ltd.20183—
+11K172771Epic Pro 940Biolase, Inc.20171—
+11K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+11K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+11K163222Discovery Pico FamilyQuanta System Spa201630—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K260138LUNE PureHygieneEnamel Pure20260—
+12K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+12K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+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—
+12K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+12K252447Picosecond laser device (BMPS4)Hebei Newangie Technology 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—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+12K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+12K243737Inbella RF SystemInbella Medical, Inc.20250—
+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—
+12K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+12K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+12K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+12K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+12K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+12K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+12K172144CoolSculpting SystemZeltiq Aesthetics20177—
+12K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+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—
+13K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+13K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+14K213889PicoStarAsclepion Laser Technologies GmbH20220—
+14K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+15K202503ChromeQuanta System Spa202012—
+16K253765Vanish ProDdc Technologies, Inc.20260—
+16K241527Pastelle ProWontech Co., Ltd.20253—
+16K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+16K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+16K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—