Duns Number:080429881
Device Description: Laser Device for promotion of hair growth.
Catalog Number
-
Brand Name
Hair Laser Helmet
Version/Model Number
RB2040
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
-
Product Code
OAP
Product Code Name
Laser, Comb, Hair
Public Device Record Key
c018af81-988d-47fc-b1a3-72b6b7884acb
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
October 04, 2018
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. | 11 |