Devices / IPL & laser hair removal

SmoothSkin

Pure

Discontinued — see SmoothSkin Pure Adapt, SmoothSkin Pure Fit, SmoothSkin Pure Switch.

FDA cleared · K200184

“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

What it’s cleared for

The SmoothSkin Pure Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure is also indicated for the permanent reduction in hair regrowth, defined as the long- term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

From the FDA filing (K200184, page 3) — verbatim — not yet human-reviewed · retrieved 2026-10-19

Who should skip it

Safety notes

The FDA record

Yes — the FDA record names SmoothSkin Pure.

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.

Is SmoothSkin Pure FDA cleared?

Specifications

Return window (days; conditions apply)
30 · Source — not yet human-reviewed · retrieved 2026-10-19
Current policy; Final Sale excluded.

Technical details appear only after we’ve checked and cited a source.

Price

Discontinued

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Where to buy

Discontinued — see SmoothSkin Pure Adapt, SmoothSkin Pure Fit, SmoothSkin Pure Switch.

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