Catalog Number

7290015418621

Brand Name

Silk'n

Version/Model Number

Blue

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

-

Product Code

OLP

Product Code Name

Over-The-Counter Powered Light Based Laser For Acne

Public Device Record Key

5fcb51ec-07cc-4d63-bc02-f13691a01d8f

Public Version Date

November 16, 2020

Public Version Number

7

DI Record Publish Date

August 15, 2016

Package DI Number

27290015418625

Quantity per Package

6

Contains DI Package

17290015418628

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box