K250308

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)

510(k) number: K250308
Device name: 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)
Applicant: Dongguan Boyuan Intelligent Technology Co.,Ltd CN
Product code: OAP — Laser, Comb, Hair
Decision date: 2025-04-29
Date received: 2025-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Physical Medicine

PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain

Also available from FDA: K250308.pdf

Official FDA record: K250308

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.