510(k) Report

Devices descending from K972767

1,179 later devices reach Candela Gentlelase GL Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+10K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+10K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+10K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+10K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+10K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+10K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K244060eCO2 3DLutronic Corporation20250—
+10K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+10K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+10K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+10K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+10K243957PicoalexWontech Co., Ltd.20250—
+10K243587PureLift GLOWXtreem Pulse, LLC20251—
+10K243330LYMA Laser PROLyma Life, Ltd.20250—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+10K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+10K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+10K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+10K241406LavieenWontech Co., Ltd.20242—
+10K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+10K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+10K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+10K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+10K221873NeoGen PSR SystemEnergist Limited20230—
+10K220853PicoWay Laser SystemCandela Corporation20221—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+10K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K212127PicocaremajestyWontech Co., Ltd.20226—
+10K201773PicohiHironic Co., Ltd.20215—
+10K211444CellFX SystemPulse Biosciences, Inc.20213—
+10K210948Omnilux CLEARGlobalmed Technologies202139—
+10K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+10K202988Tixel SystemNovoxel, Ltd.20211—
+10K193201BTL-785FBtl20208—
+10K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+10K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+10K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+10K191065Venus VivaTMVenus Concept USA, Inc.20200—
+10K191855EmFace DeviceInmode MD, Ltd.20191—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+10K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+10K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+10K181095RF-ReliefEl Global Trade, Ltd.20181—
+10K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+10K172302InMode PLUS SystemInmode MD, Ltd.201713—
+10K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+10K172096FraxisIlooda Co,., Ltd.20172—
+10K170325Secret RFIlooda Co,., Ltd.201710—
+10K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+10K160470SculpSureCynosure, Inc.201620—
+10K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+10K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+10K151629Guardian 1000Quanta System Spa20150—
+10K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+10K150724SculpSureCynosure, Inc.201521—
+10K150230SculpSureCynosure, Inc.201521—
+10K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+10K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+10K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+10K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+10K121286EPIC 10Biolase Technology, Inc.201231—
+10K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+10K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+10K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+10K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+10K094049Stlase Diode LaserDental Photonics, Inc.201023—
+10K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+10K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+10K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+11K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+11K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+11K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+11K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+11K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+11K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+11K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+11K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+11K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+11K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+11K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+11K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+11K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+11K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+11K252093Light Therapy Mask (1019055)Merchsource, LLC20250—