510(k) Report

Devices descending from K201773

5 later devices reach Picohi through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253342PICO-KSpeclipse, Inc.20251—
+1K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+1K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+2K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+2K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—