K252264

MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)

510(k) number: K252264
Device name: MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)
Applicant: Shenzhen Zhenxing Ruitong Technology Co., Ltd. CN
Product code: OHS — Light Based Over The Counter Wrinkle Reduction
Decision date: 2025-10-17
Date received: 2025-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain

Also available from FDA: K252264.pdf

Official FDA record: K252264

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