Catalog Number

-

Brand Name

Pulsaderm RED LED Skin Renewal

Version/Model Number

PD5000R

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

K141308

Product Code

OHS

Product Code Name

Light Based Over The Counter Wrinkle Reduction

Public Device Record Key

8e487f93-b393-4e87-80d5-d481a5ea85cf

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-