510(k) Report

Devices descending from K013028

906 later devices reach Palomar SLP 1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K232499IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)Shenzhen Lescolton Electrical Appliance Co., Ltd.20234—
+8K232183IPL Hair Removal Device, Model (s): T1, T2, T3, T7, T10Shenzhen Koli Technology Co.,Ltd20230—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+8K230097IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108Shenzhen Bsx Technology Electronics Co., Ltd.20238—
+8K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+8K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K222710IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd.20220—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K222432IPL Hair Removal Device, Model (s): KCA423, KCA437, KCA439Hunan Guangye Biotechnology Co., Ltd.20220—
+8K222316IPL Hair Removal DeviceShenzhen Goodwind Technology Development Co., Ltd.20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K221466IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17Shenzhen Century Dongyuan Technology CO, Ltd.20220—
+8K221407truSculpt iDCutera, Inc.20222—
+8K212472AgeJetTriworks Group Srl20220—
+8K220248Home use hair removal deviceShenzhen Mareal Tech Co., Ltd.20228—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K220669IPL HAIR REMOVAL HANDSET, Model: IPL-666Shenzhen Junbobeauty Technology Co., Ltd.20222—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K220222IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd.202213—
+8K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+8K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd.202226—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K213020IPL hair removal machineShenzhen Borria Technology Co., Ltd.20210—
+8K201773PicohiHironic Co., Ltd.20215—
+8K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+8K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K202199BTL-899STBtl20216—
+8K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+8K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+8K200693K2 MobileHulaser, Inc.20202—
+8K202041Opera EvoQuanta System Spa20200—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+8K193486Epic 980Biolase, Inc.20202—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K191086ExciplexClarteis20194—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+8K190678TempSureCynosure, Inc.201914—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K182365TempSure SystemCynosure, Inc.201815—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K173677InMode VLazeInmode MD, Ltd.20183—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+8K170116Thermi Injectable RF ElectrodesThermi20172—
+8K163128Epic ProBiolase, Inc.201716—
+8K163190InMode RF SystemInmode MD, Ltd.20160—
+8K163222Discovery Pico FamilyQuanta System Spa201630—
+8K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+8K142924Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyShaser, Inc.20150—
+8K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP…Shenzhen Xiazhifeng Electronic Co., Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+9K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—