510(k) Report

Devices descending from K083899

198 later devices reach Revlite Q-Switched ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160368EVO platformQuanta System Spa201636—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152012EVO platformQuanta System Spa201537—
+4K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K261570Picosure WorkstationCynosure, LLC20260—
+5K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+5K252369Boston Pico755Boston Aesthetics, Inc.20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+5K243957PicoalexWontech Co., Ltd.20250—
+5K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+5K241656Eneka SelectifTermosalud20241—
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K232236EchoQuanta System Spa20230—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K220853PicoWay Laser SystemCandela Corporation20221—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K212127PicocaremajestyWontech Co., Ltd.20226—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201773PicohiHironic Co., Ltd.20215—
+5K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+5K192856MT OneM&T S.R.L.20202—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K172413MT ONEM&T S.R.L.20175—
+5K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+6K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+6K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+6K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+6K240752Deka ToroEl.En S.P.A.20240—
+6K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+6K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+6K22079410PLTentech Co., Ltd.20220—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200616E>EyeCE-Swin20200—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K213889PicoStarAsclepion Laser Technologies GmbH20220—
+8K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K202503ChromeQuanta System Spa202012—
+10K253765Vanish ProDdc Technologies, Inc.20260—
+10K250281Deka LotusEl.En S.P.A.20250—
+10K241527Pastelle ProWontech Co., Ltd.20253—
+10K233473Deka LotusEl.En S.P.A.20241—
+10K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+10K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+10K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+11K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—