510(k) Report

Devices descending from K140727

47 later devices reach Cutera Picosecond Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162755PicocareWontech Co., Ltd.20179—
+1K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+1K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+2K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+2K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+2K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+2K181272Picocare FamilyWontech Co., Ltd.20188—
+2K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+2K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+2K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+2K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+3K212663Helios IV 785Laseroptek Co., Ltd.20223—
+3K212127PicocaremajestyWontech Co., Ltd.20226—
+3K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+3K191685PicoWay Laser SystemCandela Corporation201920—
+3K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+3K182997enlighten III Laser SystemCutera, Inc.20180—
+3K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+4K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+4K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+4K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+4K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+4K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+4K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+4K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+4K220853PicoWay Laser SystemCandela Corporation20221—
+4K201773PicohiHironic Co., Ltd.20215—
+4K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+4K202172StarWalkerFotona D.O.O.20203—
+4K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+4K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+5K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+5K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K240752Deka ToroEl.En S.P.A.20240—
+5K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+5K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+5K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+5K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—