Hair Laser Helmet - Laser Device for promotion of hair growth. - PULSADERM LLC

Duns Number:080429881

Device Description: Laser Device for promotion of hair growth.

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More Product Details

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

Product Characteristics

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 Details

Product Code

OAP

Product Code Name

Laser, Comb, Hair

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PULSADERM LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11