# K240587: SmoothSkin Pure Unplugged (SSB3)

- Pathway: 510(k) (Special)
- Applicant: Cyden Limited
- Decided: Mar 29, 2024 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
Longest line of descent: 16 generations back to K950019 (1995). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213692: SmoothSkin Pure Mini, Cyden Limited (2022) Summary page 5.
- K143003: iPulse Smooth Skin Gold Hair Removal System, Ipulse Limited (2015) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K240587
Methodology: https://510kreport.com/methodology