# K200786: Venus Epileve

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept USA, Inc.
- Decided: Jun 9, 2020 after 75 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
Longest line of descent: 19 generations back to K910422 (1992). 258 ancestors in all.
No later device cites it as a predicate yet.
0 of 259 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162765: Venus Velocity Diode Laser System, Venus Concept, Ltd. (2017) Summary page 4.

## Indications for use
The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for: * Hair removal, * Permanent hair reduction (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); and * Treatment of pseudofolliculitis barbae.

Source page: https://510kreport.com/device/K200786
Methodology: https://510kreport.com/methodology