510(k) Report

Devices descending from K885026

767 later devices reach Houva II Uvb through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K222556BTL-785XBTL Industries, Inc.20235—
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+9K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+9K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+9K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+9K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K210084SilkroHironic Co., Ltd.20223—
+9K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K212155TheraFace LEDTheragun, Inc.202142—
+9K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+9K201773PicohiHironic Co., Ltd.20215—
+9K212238TheraFace MicrocurrentTheragun, Inc.20210—
+9K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K200786Venus EpileveVenus Concept USA, Inc.20200—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K192430Epic 980Biolase, Inc.20195—
+9K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+9K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+9K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+9K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+9K173677InMode VLazeInmode MD, Ltd.20183—
+9K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+9K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170500SIROLaser Advance+Dentsply Sirona201721—
+9K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+9K163222Discovery Pico FamilyQuanta System Spa201630—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K161185LUCERNA Dental LaserViax Dental Lab20160—
+9K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+9K153566Magma SystemFormatk Systems, Ltd.20162—
+9K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+9K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+9K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+9K131839DC 7Dc International, LLC20130—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K130465EPIC 10SBiolase Technology, Inc.20130—
+9K111689StlaseDental Photonics, Inc.201222—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+10K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+10K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+10K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+10K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+10K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+10K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+10K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+10K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+10K251730LIA Console (542-7)Leadoptik, Inc.20250—
+10K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+10K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+10K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+10K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—