Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
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.
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.
The SSC1 device is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
Summary parsed at:2026-06-11 04:49:00 UTC
