K243362
- 510(k) number
- K243362
- Device name
- SmoothSkin Pure Switch (SSC1)
- Applicant
- Cyden Limited GB
- Product code
- OHT — Light Based Over-The-Counter Hair Removal
- Decision date
- 2024-11-27
- Date received
- 2024-10-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243362.pdf
Official FDA record: K243362
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.