Catalog Number

-

Brand Name

Hair Boom69, Hair Boom

Version/Model Number

Hair Boom69, Hair Boom

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

K191154

Product Code

OAP

Product Code Name

Laser, Comb, Hair

Public Device Record Key

1bf018f3-c2bf-4f66-8547-41a2ec46941a

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

October 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-