510(k) Report

Devices descending from K241527

3 later devices reach Pastelle Pro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253344Bellus-QSpeclipse, Inc.20250—
+1K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+1K250165PastelleWontech Co., Ltd.20250—