Product code OHT· 21 CFR 878.4810
Product code
Predicate devices
FDA 510(k) registration fields
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.
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.
Summary parsed at:2026-06-11 04:26:43 UTC
No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
SmoothSkin Pure Adapt (SSG3)
1 submission cite K200184 as a predicate
