K261253

Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)

510(k) number: K261253
Device name: Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)
Applicant: Ziree Co., Ltd. CN
Product code: OAP — Laser, Comb, Hair
Decision date: 2026-06-26
Date received: 2026-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Physical Medicine

Also available from FDA: K261253.pdf

Official FDA record: K261253

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