K252994

LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)

510(k) number
K252994
Device name
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)
Applicant
Guangdong Ace-Tec Co., Ltd. CN
Product code
OHS — Light Based Over The Counter Wrinkle Reduction
Decision date
2025-12-08
Date received
2025-09-18
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K252994.pdf

Official FDA record: K252994
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.