K251545
- 510(k) number
- K251545
- Device name
- Intense Pulsed Light Therapy Device (MMABM-1)
- Applicant
- Micowey Medical Equipment (Guangxi) Co., Ltd. CN
- Product code
- ONF — Powered Light Based Non-Laser Surgical Instrument Wi
- Decision date
- 2025-09-04
- Date received
- 2025-05-20
- 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: K251545.pdf
Official FDA record: K251545
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.