510(k) Report

Devices descending from K191685

20 later devices reach PicoWay Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+1K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+1K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+1K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+1K220853PicoWay Laser SystemCandela Corporation20221—
+1K201773PicohiHironic Co., Ltd.20215—
+1K202172StarWalkerFotona D.O.O.20203—
+1K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+2K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+2K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+2K253342PICO-KSpeclipse, Inc.20251—
+2K253344Bellus-QSpeclipse, Inc.20250—
+2K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+2K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+2K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+2K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+2K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+2K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+2K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+3K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—