Catalog Number

FA7-1450J

Brand Name

7LS

Version/Model Number

FA7-1450J

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

K162098

Product Code

OHS

Product Code Name

Light Based Over The Counter Wrinkle Reduction

Public Device Record Key

99b1a3b2-47db-4ba5-b6ae-e6b7ef51d5a3

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

February 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-