Devices / IPL & laser hair removal

SmoothSkin

Pure Switch

FDA cleared · K243362

“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 Switch is intended for the removal of unwanted hair. The SmoothSkin Pure Switch 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 (K243362, page 4) — verbatim — not yet human-reviewed · retrieved 2026-10-20

Who should skip it

Safety notes

The FDA record

Yes — the FDA record names SmoothSkin Pure Switch.

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.

Is SmoothSkin Pure Switch FDA cleared?

Specifications

Treatment areas (see source for restrictions)
body, face · Source — not yet human-reviewed · retrieved 2026-10-20
Body hair and female facial hair below cheek line only; do not generalize to male facial hair or genital areas.
Lightest supported tone
1 · Source — not yet human-reviewed · retrieved 2026-10-20
Manufacturer tone scale light through tone 5; sensor must permit treatment. No use on tone 6 or recent tan.
Darkest supported tone
5 · Source — not yet human-reviewed · retrieved 2026-10-20
Manufacturer tone scale light through tone 5; sensor must permit treatment. No use on tone 6 or recent tan.
Supported hair colours
black, dark-brown, medium-brown, light-brown · Source — not yet human-reviewed · retrieved 2026-10-20
Manufacturer states black or brown hair; no red, white, grey or blonde hair.
Coded cautions (read full instructions)
pregnancy, under-18, tattoo, photosensitive · Source — not yet human-reviewed · retrieved 2026-10-20
Partial coded list; complete manual contains further contraindications and warnings.
Session minutes (see source for treatment area)
7 · Source — not yet human-reviewed · retrieved 2026-10-20
Manufacturer full-body timing claim; individual time varies.
Cordless
No · Source — not yet human-reviewed · retrieved 2026-10-20
Warranty (years)
2 · Source — not yet human-reviewed · retrieved 2026-10-20
Return window (days; conditions apply)
30 · Source — not yet human-reviewed · retrieved 2026-10-19
Direct purchases with original box; Final Sale excluded; customer pays return shipping.

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

Price

USD 349.0 · Source · retrieved 2026-10-20

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Where to buy

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