K250253
- 510(k) number
- K250253
- Device name
- IPL Hair Removal Device (KCA511/KCA516/KCA522)
- Applicant
- Dongguan Boyuan Intelligent Technology Co.,Ltd CN
- Product code
- OHT — Light Based Over-The-Counter Hair Removal
- Decision date
- 2025-05-06
- Date received
- 2025-01-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K250253.pdf
Official FDA record: K250253
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.