Duns Number:342234451
Device Description: Scanned diode laser 808 nm and 755 nm for hair reduction
Catalog Number
1060
Brand Name
TwinScan 808/755 Laser System
Version/Model Number
1060
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K192269
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
9361b81d-f9fa-4e90-9fbc-c1ccb64477c6
Public Version Date
December 09, 2019
Public Version Number
1
DI Record Publish Date
November 29, 2019
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. | 5 |