510(k) Report

Devices descending from K971193

39 later devices reach Laseaway Long Pulse and Q-Switched Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121162Polaris Q-Switch Ruby SystemSandstone Medical Technologies, LLC201238—
+2K152012EVO platformQuanta System Spa201537—
+3K160368EVO platformQuanta System Spa201636—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+4K163222Discovery Pico FamilyQuanta System Spa201630—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+6K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+7K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+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—
+7K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+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—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+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—
+10K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+10K253344Bellus-QSpeclipse, Inc.20250—
+10K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+10K250165PastelleWontech Co., Ltd.20250—