Norlase LION photocoagulator - The Norlase LION Photocoagulator is intended to - Norlase ApS

Duns Number:305483903

Device Description: The Norlase LION Photocoagulator is intended to be used in ophthalmic laser procedures inc The Norlase LION Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty

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More Product Details

Catalog Number

-

Brand Name

Norlase LION photocoagulator

Version/Model Number

N006-9200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

58aea29d-cb65-461f-8942-a91ff0ec1f09

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

August 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORLASE APS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2