# K162765: Venus Velocity Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept, Ltd.
- Decided: Jan 11, 2017 after 103 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: 18 generations back to K910422 (1992). 257 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 259 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120622: Palomar Vectus Laser, Palomar Medical Technologies, Inc. (2012) Summary page 4.
- K151947: LightSheer Desire Light Laser System, Lumenis, Ltd. (2015) Summary page 4.

## Most influential descendants
- K200786: Venus Epileve (2020), 0 descendants of its own

## Indications for use
The Venus Velocity is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for: x Hair removal; x 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 x Treatment of pseudofolliculitis barbae.

Source page: https://510kreport.com/device/K162765
Methodology: https://510kreport.com/methodology