Catalog Number

-

Brand Name

Opelaser

Version/Model Number

Opelaser Lite Ⅱ

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120932

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

01443513-08c3-4727-8e3a-a287548190e9

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

May 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-