510(k) Report

Devices descending from K202991

3 later devices reach Fotona XPulse Pro Laser Platform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+1K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+2K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—