K251914

IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)

510(k) number: K251914
Device name: IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)
Applicant: Miley Technology (Hebei) Co., Ltd. CN
Product code: OHT — Light Based Over-The-Counter Hair Removal
Decision date: 2025-09-15
Date received: 2025-06-23
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: K251914.pdf

Official FDA record: K251914

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