Duns Number:104265165
Device Description: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
Catalog Number
856823006732
Brand Name
HairMax
Version/Model Number
Professional 12-LC
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
K103368,K110233,K112524
Product Code
OAP
Product Code Name
Laser, Comb, Hair
Public Device Record Key
75af0d4b-efad-4722-8f59-4bb0801aa253
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 10, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 15 |