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
+7K151655CO2RE SystemSyneron Medical, Ltd.20151—
+7K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+7K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+7K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+7K150051ExiliteBTL Industries, Inc.20150—
+7K140471Pro X Otc 5La Lumiere, LLC2015107—
+7K141868Tria FanpTria Beauty, Inc.20140—
+7K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+7K142093V20 SystemViora, Ltd.201432—
+7K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+7K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+7K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+7K133364Picosure WorkstationCynosure, Inc.201451—
+7K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+7K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+7K131113Biophotas CellumaBiophotas, Inc.201455—
+7K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+7K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+7K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+7K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+7K121346Picosure WorkstationCynosure, Inc.201287—
+7K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+7K113588Spectra Laser SystemLutronic Corporation201282—
+7K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+7K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+7K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+7K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+7K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+7K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+7K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+7K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+7K100558Quanta Diode Laser SystemQuanta System Spa201068—
+7K101415TheraclearTheravant Corporation20101—
+7K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+7K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+7K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+7K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+7K090094Zeltiq SystemZeltiq Aesthetics200932—
+7K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+7K081570DPL Therapy SystemLed Technologies, LLC200811
+7K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+7K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+7K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+7K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+7K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+7K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+7K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+7K080932Mosaic Laser SystemLutronic Corporation20086—
+7K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+7K080374Biosyag Medical SystemBios S.R.L.20082—
+7K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+7K070690The Life VesselCottonwood Vessel Corporation20070—
+7K070392Mosaic Laser SystemLutronic Corporation20078—
+7K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+7K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+7K052354Oculase MDBiolase Technology, Inc.20065—
+7K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+7K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+8K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K261473ChromixTermosalud S.L.20260—
+8K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+8K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+8K243854Contour Light (CL-100)Contour Research, LLC20261—
+8K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+8K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+8K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+8K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+8K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+8K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+8K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+8K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+8K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K250809Stellar M22Lumenis Be, Ltd.20250—
+8K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+8K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+8K250125LMNT O2Xplr, Ltd.20250—
+8K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+8K243488Vmat ProTermosalud20250—
+8K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+8K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+8K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+8K241102Luna 4 plusForeo, Inc.20245—
+8K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+8K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+8K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+8K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—