Duns Number:341936227
Device Description: This device is an over-the-counter tanning device emitting ultraviolet light in the UVB a This device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning of the human skin of an adult person.
Catalog Number
-
Brand Name
KBL 6700 alpha
Version/Model Number
KBL 6808 - 46/4a 1616 cpi_us
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151962
Product Code
LEJ
Product Code Name
Booth, Sun Tan
Public Device Record Key
bea0102a-873d-4bd7-a717-8dc51c3b48a6
Public Version Date
August 06, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |