510(k) Report

Devices descending from K991234

755 later devices reach The Acme Medical Aesthetic ND:Yag Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K140837Lucid LYBio-Med USA, Inc.20140—
+7K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+7K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+7K131839DC 7Dc International, LLC20130—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+7K123573Youlaser CO2 LaserQuanta System Spa201319—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+7K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+7K091115ECO2 Laser SystemLutronic Corporation200927—
+7K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+7K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+7K090525Loi SystemPalomar Medical Products, Inc.20099—
+7K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+7K080932Mosaic Laser SystemLutronic Corporation20086—
+7K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+7K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K251730LIA Console (542-7)Leadoptik, Inc.20250—
+8K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+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—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T 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—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K243488Vmat ProTermosalud20250—
+8K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K230077LaserMENeauvia North America20232—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+8K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K201773PicohiHironic Co., Ltd.20215—
+8K212082PicoreBio-Med USA, Inc.20210—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+8K202041Opera EvoQuanta System Spa20200—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+8K193426Elite iQCynosure, LLC20201—
+8K192545PotenzaJeisys Medical Incorporated202020—