About This 510(k) Submission
K250308 is an FDA 510(k) clearance for the 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), a Laser, Comb, Hair (Class II — Special Controls, product code OAP), submitted by Dongguan Boyuan Intelligent Technology Co.,Ltd (Dongguan, CN). The FDA issued a Cleared decision on April 29, 2025, 85 days after receiving the submission on February 3, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 890.5500.