Catalog Number

135-OC

Brand Name

Omnilux CLEAR

Version/Model Number

TN2112

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

K210948

Product Code

OLP

Product Code Name

Over-The-Counter Powered Light Based Laser For Acne

Public Device Record Key

48a154a0-b93d-416c-bc38-b09e1a0a14bc

Public Version Date

July 13, 2021

Public Version Number

1

DI Record Publish Date

July 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-