FDA records / IPL & laser hair removal
Is SmoothSkin Pure Switch FDA cleared?
Yes — the FDA record names SmoothSkin Pure Switch.
The model name is matched to the linked record below. Clearance is specific to the device and stated use; it is not a performance ranking.
“Cleared” means the FDA found the device substantially equivalent to one already legally sold, for a stated use. It isn’t proof it works for you. What clearance means
Follow the FDA record.
K243362 · View FDA record
- Device name in the FDA record
- SmoothSkin Pure Switch (SSC1)
- Applicant
- Cyden Limited
- Decision date
- 2024-11-27
- Product code
- OHT: Light Based Over-The-Counter Hair Removal
- Evidence
- FDA record and summary explicitly name the model; manufacturer product/manual agrees: https://smoothskin.com/products/pure-switch openFDA source; retrieved 2026-10-20.