# K200184: SmoothSkin Pure

- Pathway: 510(k) (Special)
- Applicant: Cyden Limited
- Decided: Feb 21, 2020 after 28 days
- Product code: OHT (Light Based Over-The-Counter Hair Removal)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K233782: SmoothSkin Pure Adapt (SSG3) (2023), 2 descendants of its own
- K243362: SmoothSkin Pure Switch (SSC1) (2024), 1 descendant of its own
- K261975: Braun Aura 7 (6041) (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K200184
Methodology: https://510kreport.com/methodology