Catalog Number

HU-FG01721

Brand Name

Me

Version/Model Number

Series 14

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

9b092bd5-a8d4-4327-a919-0199a880f6ae

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-