Duns Number:002692106
Device Description: Phototherapy Unit. UVB Narrowband. 4 Connected Panels, attached to a wall, wrap around pat Phototherapy Unit. UVB Narrowband. 4 Connected Panels, attached to a wall, wrap around patient. 16 lamps, each 72" in height.
Catalog Number
1600B
Brand Name
UVBioTek
Version/Model Number
1600B
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
K935526
Product Code
FTC
Product Code Name
Light, Ultraviolet, Dermatological
Public Device Record Key
fe88140e-380b-4b58-a350-fc07003a2fb8
Public Version Date
December 21, 2018
Public Version Number
4
DI Record Publish Date
February 09, 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. | 21 |
| U | Unclassified | 3 |