510(k) Report

Devices descending from K933057

1,153 later devices reach Multilite Erbium:Yag Surgical Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+9K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+9K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+9K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K244060eCO2 3DLutronic Corporation20250—
+9K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+9K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K243587PureLift GLOWXtreem Pulse, LLC20251—
+9K243330LYMA Laser PROLyma Life, Ltd.20250—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+9K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+9K241406LavieenWontech Co., Ltd.20242—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+9K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+9K222556BTL-785XBTL Industries, Inc.20235—
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K221873NeoGen PSR SystemEnergist Limited20230—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K210084SilkroHironic Co., Ltd.20223—
+9K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+9K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K201773PicohiHironic Co., Ltd.20215—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K210948Omnilux CLEARGlobalmed Technologies202139—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K202041Opera EvoQuanta System Spa20200—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K201111GentleMax Pro PlusCandela Corporation20203—
+9K200110SANDRO DualWontech Co., Ltd.20202—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+9K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+9K183452Vbeam Prima Laser SystemCandela Corp.20191—
+9K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+9K181510Echolaser X4El.En Electronic Engineering Spa20183—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K161669Waterlase ExpressBiolase, Inc.201621—
+9K152737Lite TouchFocus Medical, LLC20160—
+9K151629Guardian 1000Quanta System Spa20150—
+9K151306SoleaConvergent Dental, Inc.20151—
+9K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+9K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+9K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+9K130420SOLEAConvergent Dental, Inc.201321
+9K121286EPIC 10Biolase Technology, Inc.201231—
+9K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+9K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+9K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+9K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+9K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+9K094049Stlase Diode LaserDental Photonics, Inc.201023—
+9K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+9K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+10K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+10K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+10K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+10K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+10K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K260632Laser Thermal Therapy KitElesta S.P.A20260—
+10K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+10K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology 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—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—