Catalog Number

-

Brand Name

Norlase Leaf photocoagulator

Version/Model Number

N005-9010-03

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

Yes

FDA Premarket Submission

K190083

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Public Device Record Key

f36a99ea-1cdc-41ac-8b31-283bf38623b6

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

October 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-