510(k) Report

Devices descending from K800617

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+9K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+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—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+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—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K242859VEGAIbramed Equipamentos Médicos20250—
+9K251843Erchonia EVRLErchonia Corporation20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+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—
+9K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K250200InbellaBody SystemInbella Medical, Inc.20250—
+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—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+9K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K241656Eneka SelectifTermosalud20241—
+9K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+9K241600DermablateAsclepion Laser Technologies GmbH20240—
+9K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+9K233473Deka LotusEl.En S.P.A.20241—
+9K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+9K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+9K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+9K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+9K232236EchoQuanta System Spa20230—
+9K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+9K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+9K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+9K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+9K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K230293TheraFace MaskTherabody, Inc.202316—
+9K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+9K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+9K223805AgnesAgnes Medical Co., Ltd.20233—
+9K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+9K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+9K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+9K222221Deka HelixEl.En Electronic Engineering Spa20231—
+9K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+9K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+9K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K213674CellFX SystemPulse Biosciences, Inc.20220—
+9K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+9K222075CellFX SystemPulse Biosciences, Inc.20220—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K221671CellFX® SystemPulse Biosciences, Inc.20220—
+9K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+9K221407truSculpt iDCutera, Inc.20222—
+9K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+9K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+9K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+9K212155TheraFace LEDTheragun, Inc.202142—
+9K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+9K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+9K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+9K212238TheraFace MicrocurrentTheragun, Inc.20210—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+9K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+9K202199BTL-899STBtl20216—
+9K193266MIINMedico USA, Inc.20210—