K232845
- 510(k) number
- K232845
- Device name
- IPL Cooling Hair Removal Device
- Applicant
- Shenzhen Siken 3D Technology Development Co., Ltd. CN
- Product code
- OHT — Light Based Over-The-Counter Hair Removal
- Decision date
- 2023-11-14
- Date received
- 2023-09-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232845.pdf
Official FDA record: K232845
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.