Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The SmoothSkin Pure Unplugged is intended for the removal of unwanted hair. The SmoothSkin Pure Unplugged 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 Unplugged is intended for the removal of unwanted hair. The SmoothSkin Pure Unplugged 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 Unplugged is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is battery powered and charged by mains. The device consists of the handset with removal battery pack, Handset Dock station, and AC Adapter. AC mains is fed to the AC Adapter and converted to DC to charge the battery pack via the docking station contact pins, the device cannot be used when charging. The battery pack 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 04:45:02 UTC
SmoothSkin Pure Mini
K240587 references 1 predicate/reference device
No later 510(k)s cite this device yet
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