FDA records / IPL & laser hair removal
Is SmoothSkin Pure FDA cleared?
Yes — the FDA record names SmoothSkin Pure.
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.
K200184 · View FDA record
- Device name in the FDA record
- SmoothSkin Pure
- Applicant
- Cyden Limited
- Decision date
- 2020-02-21
- Product code
- OHT: Light Based Over-The-Counter Hair Removal
- Evidence
- FDA record names this model; retail model variants are not inferred. openFDA source; retrieved 2026-10-19.