Duns Number:341936227
Device Description: This device is an over-the-counter device emitting ultraviolet light in the UVB and UVA re This device is an over-the-counter 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 7000 alpha extraSun+
Version/Model Number
KBL 6808 - 46-6T12/4g 1616 int us (T)
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
1db4d073-b866-444a-bb1b-9c11aa42199d
Public Version Date
August 10, 2021
Public Version Number
1
DI Record Publish Date
August 02, 2021
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 |