510(k) Report

Devices descending from K850668

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+11K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+11K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+11K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+11K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+11K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+11K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+11K212663Helios IV 785Laseroptek Co., Ltd.20223—
+11K210084SilkroHironic Co., Ltd.20223—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+11K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+11K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+11K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+11K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+11K212107ReversoIntelis Instruments, Ltd.20211—
+11K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+11K210948Omnilux CLEARGlobalmed Technologies202139—
+11K210226PicoSure WorkstationCynosure, LLC20213—
+11K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+11K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+11K201685PotenzaJeisys Medical, Inc.20219—
+11K201735PlaDuo SystemShenB Co., Ltd.20203—
+11K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+11K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+11K193426Elite iQCynosure, LLC20201—
+11K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+11K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+11K192224BTL-899Btl20198—
+11K191685PicoWay Laser SystemCandela Corporation201920—
+11K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+11K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+11K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+11K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+11K182997enlighten III Laser SystemCutera, Inc.20180—
+11K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+11K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+11K181272Picocare FamilyWontech Co., Ltd.20188—
+11K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+11K173700PICOPLUS Laser SystemLutronic Corporation20187—
+11K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+11K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+11K171262TempSureCynosure, Inc.201716—
+11K172004truSculptCutera, Inc.20173—
+11K170637sensiFirmEl Global Trade, Ltd.20173—
+11K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+11K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+11K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+11K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+11K162781Magma SparkFormatk Systems, Ltd.20160—
+11K161043Profound SystemSyneron Candela Corporation20160—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+11K161661Thermi RF AccessoriesThermi20163—
+11K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+11K152731XP1100 RFBTL Industries, Inc.20160—
+11K153568InMode Plus SystemInmode MD, Ltd.201618—
+11K160368EVO platformQuanta System Spa201636—
+11K151793InMode RF SystemInmode MD, Ltd.20161—
+11K152012EVO platformQuanta System Spa201537—
+11K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+11K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+12K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+12K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+12K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+12K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+12K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+12K261570Picosure WorkstationCynosure, LLC20260—
+12K260138LUNE PureHygieneEnamel Pure20260—
+12K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+12K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+12K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+12K252369Boston Pico755Boston Aesthetics, Inc.20260—
+12K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+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—
+12K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+12K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+12K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+12K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+12K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+12K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+12K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+12K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+12K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+12K250809Stellar M22Lumenis Be, Ltd.20250—
+12K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+12K243957PicoalexWontech Co., Ltd.20250—
+12K250281Deka LotusEl.En S.P.A.20250—
+12K250200InbellaBody SystemInbella Medical, Inc.20250—
+12K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+12K243929Oligio XWontech Co., Ltd.20250—
+12K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+12K231216PotenzaJeisys Medical, Inc.20244—
+12K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+12K231287PotenzaJeisys Medical, Inc.20241—