510(k) Report

Devices descending from K850668

1,030 later devices reach Electrosurgical Unit 774 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+12K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+12K233123SilkroHironic Co., Ltd.20241—
+12K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+12K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+12K233099GladiatorRohrer Aesthetics, LLC20240—
+12K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+12K240999Legend X Applicator VOPollogen, Ltd.20241—
+12K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+12K230837PlazMagikAgnes Medical Co., Ltd.20240—
+12K233143PiXel8-RevealRohrer Aesthetics20240—
+12K233147PiXel8-RFRohrer Aesthetics20230—
+12K232223PlaDuo SystemShenB Co., Ltd.20230—
+12K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+12K222790F65 Laser SystemLumenis Be, Ltd.20233—
+12K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+12K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+12K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+12K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+12K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+12K222221Deka HelixEl.En Electronic Engineering Spa20231—
+12K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+12K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+12K220853PicoWay Laser SystemCandela Corporation20221—
+12K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+12K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+12K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+12K221407truSculpt iDCutera, Inc.20222—
+12K212472AgeJetTriworks Group Srl20220—
+12K211000AcutronIlooda Co,., Ltd.20220—
+12K212127PicocaremajestyWontech Co., Ltd.20226—
+12K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+12K201773PicohiHironic Co., Ltd.20215—
+12K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+12K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+12K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+12K202199BTL-899STBtl20216—
+12K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+12K191855EmFace DeviceInmode MD, Ltd.20191—
+12K190678TempSureCynosure, Inc.201914—
+12K182365TempSure SystemCynosure, Inc.201815—
+12K181095RF-ReliefEl Global Trade, Ltd.20181—
+12K173677InMode VLazeInmode MD, Ltd.20183—
+12K172302InMode PLUS SystemInmode MD, Ltd.201713—
+12K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+12K170116Thermi Injectable RF ElectrodesThermi20172—
+12K163190InMode RF SystemInmode MD, Ltd.20160—
+12K163222Discovery Pico FamilyQuanta System Spa201630—
+12K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+13K254185Potenza PrimeJeisys Medical Incorporated20260—
+13K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+13K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+13K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+13K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+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—
+13K253803MILAN SystemLumenis Be, Ltd.20260—
+13K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+13K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+13K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+13K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+13K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+13K251254Ignite RF SystemInMode, Ltd.20260—
+13K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+13K252367InbellaMulti SystemInbella Medical, Inc.20250—
+13K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+13K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+13K251334New Doublo 2.0Hironic Co., Ltd.20250—
+13K250734OptiLUV DevicePollogen, Ltd.20250—
+13K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+13K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+13K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+13K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+13K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+13K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+13K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+13K242349FoLixLumenis Be, Ltd.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—
+13K233766Geneo X ElitePollogen, Ltd.20240—
+13K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+13K233642InMode RF SystemInMode, Ltd.20244—
+13K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+13K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+13K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+13K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+13K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+13K223110truSculpt iDCutera, Inc.20221—
+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—
+13K211107BTL-899 FPBTL Industries, Inc.20213—
+13K200241TempSure SystemCynosure, LLC202013—
+13K183450EmBody SystemInmode MD, Ltd.20198—
+13K180406Ellipse YdunEllipse A/S20180—
+13K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+14K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+14K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+14K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—