510(k) Report

Devices descending from K024189

328 later devices reach Nlite System, Model#: A00-1025/A00-1033 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K234057NirvanaEl.En S.P.A.20240—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K232236EchoQuanta System Spa20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K220853PicoWay Laser SystemCandela Corporation20221—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K212127PicocaremajestyWontech Co., Ltd.20226—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K201773PicohiHironic Co., Ltd.20215—
+7K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K173677InMode VLazeInmode MD, Ltd.20183—
+7K172413MT ONEM&T S.R.L.20175—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+7K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+7K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+8K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+8K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+8K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+8K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+8K233473Deka LotusEl.En S.P.A.20241—
+8K240752Deka ToroEl.En S.P.A.20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K210084SilkroHironic Co., Ltd.20223—
+8K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K153229SuperbiumBios S.R.L.20162—
+8K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+8K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+8K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+8K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K241270BTL-754BTL Industries, Inc.20251—
+9K233123SilkroHironic Co., Ltd.20241—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K230077LaserMENeauvia North America20232—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+9K193426Elite iQCynosure, LLC20201—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+9K163196ACTION II Laser SystemLutronic Corporation20170—
+9K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+9K142860Lumenis M22 SystemLumenis, Ltd.2015381
+10K251334New Doublo 2.0Hironic Co., Ltd.20250—
+10K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+10K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+10K200786Venus EpileveVenus Concept USA, Inc.20200—