510(k) K252414— Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)

Substantially Equivalent

Shenzhen Kaiyan Medical Equipment Co., Ltd.

Clearance details

Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
Product code: Code OAP
Advisory panel: Physical Medicine
Date received: 2025-08-01
Decision date: 2025-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.