# K160968: iPulse SmoothSkin Gold Hair Removal Device

- Pathway: 510(k) (Traditional)
- Applicant: Cyden Limited
- Decided: Apr 14, 2016 after 8 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). 50 ancestors in all.
117 later devices descend from it; 27 cite it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143003: iPulse Smooth Skin Gold Hair Removal System, Ipulse Limited (2015) Summary page 4.

## Most influential descendants
- K161428: PerfectSmooth (2017), 115 descendants of its own
- K181568: IPL Salon Hair Reduction System (2018), 88 descendants of its own
- K192432: IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130 (2019), 66 descendants of its own
- K173813: IPL Hair Removal Device Joy Version (2018), 36 descendants of its own
- K212318: IPL Hair Removal (2022), 26 descendants of its own

## Indications for use
The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse SmoothSkin Gold 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/K160968
Methodology: https://510kreport.com/methodology