510(k) Report

Devices descending from K070805

150 later devices reach Ultrawave II EX 1320 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K202172StarWalkerFotona D.O.O.20203—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200616E>EyeCE-Swin20200—
+6K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+7K213889PicoStarAsclepion Laser Technologies GmbH20220—
+7K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K202503ChromeQuanta System Spa202012—
+9K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+9K253765Vanish ProDdc Technologies, Inc.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K241527Pastelle ProWontech Co., Ltd.20253—
+9K240752Deka ToroEl.En S.P.A.20240—
+9K233473Deka LotusEl.En S.P.A.20241—
+9K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+9K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+9K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+10K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+10K250165PastelleWontech Co., Ltd.20250—