# K170734: Venus Silk.expert

- Pathway: 510(k) (Special)
- Applicant: Cyden Limited
- Decided: May 8, 2017 after 59 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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 Venus Silk.expert Hair Removal System is indicated for the removal of unwanted hair. The Venus Silk.expert 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 regimen.

Source page: https://510kreport.com/device/K170734
Methodology: https://510kreport.com/methodology