510(k) Report

Devices descending from K972350

978 later devices reach Model 50 Bipolar Coagulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+8K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+8K160312Fraxis DuoIlooda Co,., Ltd.201614—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K160075Accent XLAlma Lasers, Inc.20160—
+8K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+8K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+8K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+8K151655CO2RE SystemSyneron Medical, Ltd.20151—
+8K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+8K141868Tria FanpTria Beauty, Inc.20140—
+8K142910Legacy BXVenus Concept USA, Inc.201411—
+8K142093V20 SystemViora, Ltd.201432—
+8K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+8K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+8K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+8K133364Picosure WorkstationCynosure, Inc.201451—
+8K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+8K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+8K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+8K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+8K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K120510TranscendSyneron Medical, Ltd.201318—
+8K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+8K122966XP200Btl Industries, Ltd.20131—
+8K121346Picosure WorkstationCynosure, Inc.201287—
+8K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+8K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+8K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+8K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+8K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+8K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+8K081408Ellipse MultiflexEllipse A/S20087—
+9K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+9K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+9K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+9K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+9K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+9K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+9K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+9K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+9K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+9K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+9K252187Aura Glide (FC40)Aura Medical, LLC20250—
+9K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K250852CoolfaseAsterasys Co., Ltd.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K242859VEGAIbramed Equipamentos Médicos20250—
+9K251843Erchonia EVRLErchonia Corporation20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251327XERFLutronic Corporation202501
+9K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+9K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+9K251632Optimas MAX SystemInMode, Ltd.20251—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+9K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+9K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+9K242241SunnyShenB Co., Ltd.20250—
+9K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K243488Vmat ProTermosalud20250—
+9K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+9K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+9K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+9K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+9K240311JETT Medical IICompex, Spol, S.R.O.20250—
+9K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+9K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+9K241656Eneka SelectifTermosalud20241—
+9K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+9K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+9K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K240248Volnewmer™Classys, Inc.20241—
+9K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+9K233604BTL-785SBTL Industries, Inc.20243—
+9K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—