510(k) Report

Devices descending from K961748

1,230 later devices reach Medlite/Erbium Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+9K252877SANDRO DualWontech Co., Ltd.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.20250—
+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—
+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—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+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—
+9K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+9K233123SilkroHironic Co., Ltd.20241—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+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—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+9K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+9K223727LavieenWontech Co., Ltd.20234—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K230293TheraFace MaskTherabody, Inc.202316—
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+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—
+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—
+9K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+9K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+9K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K213594Echolaser X4Elesta S.P.A20221—
+9K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K213428EdgeProBiolase, Inc.20210—
+9K212155TheraFace LEDTheragun, Inc.202142—
+9K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+9K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+9K201773PicohiHironic Co., Ltd.20215—
+9K212082PicoreBio-Med USA, Inc.20210—
+9K212238TheraFace MicrocurrentTheragun, Inc.20210—
+9K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+9K202041Opera EvoQuanta System Spa20200—
+9K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K190443MMSphereGalactic Beauty, LLC201942—
+9K182669Youlaser CO2Quanta System Spa20181—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+9K170984LG Beauty Led MaskLg Electronics201793—
+9K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170322Catalys Precision Laser SystemAbbott Medical Optics, Inc.201761
+9K160691Acne Light Therapy WandZuko, Inc.201650—
+9K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—