Duns Number:332247852
Device Description: Dermatological laser with wavelengths of 755 - 950 nm. Intended for hair removal, permanen Dermatological laser with wavelengths of 755 - 950 nm. Intended for hair removal, permanent hair reduction and the treatment of benign pigmented and vascular lesions.
Catalog Number
-
Brand Name
SmoothPulse PRO
Version/Model Number
15922
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
K143519
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
e8ff6183-9116-472e-b50b-a035e71fdd68
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2016
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. | 46 |