# K163552: iPulse SmoothSkin BARE Hair Removal Device

- Pathway: 510(k) (Special)
- Applicant: Cyden Limited
- Decided: Mar 3, 2017 after 74 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The iPulse SmoothSkin BARE Hair Removal System is indicated for the removal of unwanted hair. The iPulse SmoothSkin BARE 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/K163552
Methodology: https://510kreport.com/methodology