510(k) Report

Devices descending from K944090

1,155 later devices reach Candela Alex Lazr Q-Switched Alexandrite Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K083008CoolskinElbio Co., Ltd.20092—
+6K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+6K081570DPL Therapy SystemLed Technologies, LLC200811
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+6K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+6K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+6K080932Mosaic Laser SystemLutronic Corporation20086—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K080735CryominiZimmer Elektromedizin GmbH20081—
+6K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+6K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+6K070690The Life VesselCottonwood Vessel Corporation20070—
+6K070392Mosaic Laser SystemLutronic Corporation20078—
+6K063828Diomed Delta 25Diomed, Ltd.20075—
+6K062369Iridex Oculight TXIridex Corp200673—
+6K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+6K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+6K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+6K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+6K040384Mydon CWavelight Laser Technologie AG200451—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.20260—
+7K261473ChromixTermosalud S.L.20260—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K243854Contour Light (CL-100)Contour Research, LLC20261—
+7K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+7K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+7K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+7K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+7K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+7K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+7K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+7K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K250125LMNT O2Xplr, Ltd.20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+7K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+7K243488Vmat ProTermosalud20250—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+7K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K241102Luna 4 plusForeo, Inc.20245—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+7K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd20241—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+7K233224Epilaser ProEpilady 2000, LLC20240—
+7K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+7K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+7K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+7K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+7K232236EchoQuanta System Spa20230—
+7K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+7K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+7K223147myLEDmaskMyblend20234—
+7K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K223680Eneka ProTermosalud20230—
+7K222685NIRA Model 2Dermal Photonics Corp20230—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+7K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+7K222701MANTA LaserSqualus Med, Ltd.20222—