Venus Velocity Diode Laser System

Venus Concept , Ltd.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

7

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K162765
Device name
Venus Velocity Diode Laser System
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-09-30
Decision date
2017-01-11
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

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:
- 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);
- Treatment of pseudofolliculitis barbae.

Intended Use

The Venus Velocity 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.

Device Description

The Venus Velocity consists of a console, a detachable diode laser applicator, and three interchangeable sapphire light guides/tips (small, medium, and large sizes). A water system and pump in the console distribute water to cool the handpiece and tips during device use, decreasing the likelihood of burns, discomfort, or pain during treatment. The system is also provided with a water filling kit. The device incorporates several safety features, including an emergency laser stop button, user login and password protection, and other software and hardware settings to mitigate the risk of improper energy release and ensure that system outputs are within specifications. The device also comes with goggles and patient eye protectors.

Summary parsed at:2026-06-01 05:59:01 UTC

Predicate devices

7

K162765 references 7 predicate/reference devices

Cited as predicate

1

1 submission cite K162765 as a predicate