Catalog Number

3374

Brand Name

Positively Clear

Version/Model Number

BL2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K160821

Product Code

OLP

Product Code Name

Over-The-Counter Powered Light Based Laser For Acne

Public Device Record Key

0b6f0255-ab42-48f3-8a7e-02706b78f181

Public Version Date

July 16, 2018

Public Version Number

4

DI Record Publish Date

January 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-