Catalog Number

-

Brand Name

OMNILUX

Version/Model Number

EM1258S

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K050216,K030426,K030883,K043317,K043329

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

1545aeca-d853-400b-9969-6263a77039e9

Public Version Date

May 07, 2019

Public Version Number

5

DI Record Publish Date

December 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-