Manufacturer
Venus Concept , Ltd.Venus Velocity Diode Laser System
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K162765
- Device name
- Venus Velocity Diode Laser System
- Company
- Venus Concept , Ltd.
- 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
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