Dongguan Boyuan Intelligent Technology Co.,Ltd - FDA 510(k) Cleared D...
Recent clearances: IPL Hair Removal Device (KCA511/KCA516/KCA522), Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S), LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dongguan Boyuan Intelligent Technology Co.,Ltd General & Plastic Surgery ✕
4 devices
Cleared
May 06, 2025
IPL Hair Removal Device (KCA511/KCA516/KCA522)
General & Plastic Surgery
98d
Cleared
Apr 29, 2025
Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56,...
General & Plastic Surgery
85d
Cleared
Oct 11, 2024
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
General & Plastic Surgery
106d
Cleared
Apr 03, 2024
IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506,...
General & Plastic Surgery
62d