Duns Number:533127663
Device Description: The Venus Concept Velocity Diode Laser is intended for all Fitzpatrick skin types, includi The Venus Concept Velocity Diode Laser 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.
Catalog Number
-
Brand Name
Venus Velocity
Version/Model Number
VL000001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162765
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
6869d8e7-8f1b-4359-981b-cc7b47ab9ecf
Public Version Date
May 24, 2021
Public Version Number
4
DI Record Publish Date
March 13, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |