510(k) Report

Devices descending from K971207

781 later devices reach Softlight Q-Switched (ND:Yag) Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+9K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+9K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+9K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+9K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+9K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+9K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+9K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+9K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+9K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+9K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+9K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+9K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+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—
+9K241102Luna 4 plusForeo, Inc.20245—
+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—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+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—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233224Epilaser ProEpilady 2000, LLC20240—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+9K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+9K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K201773PicohiHironic Co., Ltd.20215—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+9K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+9K200693K2 MobileHulaser, Inc.20202—
+9K202041Opera EvoQuanta System Spa20200—
+9K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+9K193486Epic 980Biolase, Inc.20202—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K191086ExciplexClarteis20194—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K180044SIROLaser BlueDentsply Sirona201812—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K163128Epic ProBiolase, Inc.201716—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+9K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+9K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+10K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—