510(k) Report

Devices descending from K974381

1,178 later devices reach Candela Gentlelase GL Dermatological Laser 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—
+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—
+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—
+9K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+9K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+9K241406LavieenWontech Co., Ltd.20242—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology 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—
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K221873NeoGen PSR SystemEnergist Limited20230—
+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—
+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—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K201773PicohiHironic Co., Ltd.20215—
+9K211444CellFX SystemPulse Biosciences, Inc.20213—
+9K210948Omnilux CLEARGlobalmed Technologies202139—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K202988Tixel SystemNovoxel, Ltd.20211—
+9K193201BTL-785FBtl20208—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+9K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K191065Venus VivaTMVenus Concept USA, Inc.20200—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+9K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+9K172096FraxisIlooda Co,., Ltd.20172—
+9K170325Secret RFIlooda Co,., Ltd.201710—
+9K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+9K160470SculpSureCynosure, Inc.201620—
+9K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+9K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+9K151629Guardian 1000Quanta System Spa20150—
+9K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+9K150724SculpSureCynosure, Inc.201521—
+9K150230SculpSureCynosure, Inc.201521—
+9K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+9K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+9K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+9K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+9K121286EPIC 10Biolase Technology, Inc.201231—
+9K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+9K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+9K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+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—
+9K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+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—
+10K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies 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—
+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—
+10K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+10K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+10K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+10K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K243139Reverso Pro SystemIndiba S. A. U.20250—