Catalog Number

-

Brand Name

Lumenis 1000 Integrated Slit Lamp

Version/Model Number

Lumenis 1000 Integrated Slit Lamp

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 02, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K052129

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

ff9fd758-4fca-4de0-9a54-739fa38f2305

Public Version Date

April 08, 2022

Public Version Number

5

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-