Catalog Number

ULTIMA 12 - KIT

Brand Name

HairMax

Version/Model Number

LaserComb Ultima 12

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

3b0baf2e-b9d2-4681-9d54-3a24f814025f

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-