# K233782: SmoothSkin Pure Adapt (SSG3)

- Pathway: 510(k) (Special)
- Applicant: Cyden Limited
- Decided: Dec 20, 2023 after 23 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
Longest line of descent: 16 generations back to K950019 (1995). 51 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200184: SmoothSkin Pure, Cyden Limited (2020) Summary page 5.
- K143003: iPulse Smooth Skin Gold Hair Removal System, Ipulse Limited (2015) Summary page 5.

## Most influential descendants
- 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 Adapt is intended for the removal of unwanted hair. The SmoothSkin Pure Adapt 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/K233782
Methodology: https://510kreport.com/methodology