Lightwalker ST-E ADVANCED - The Fotona LightWalker laser system range - FOTONA d.o.o.

Duns Number:644720625

Device Description: The Fotona LightWalker laser system range incorporates treatment lasers that operate in th

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More Product Details

Catalog Number

-

Brand Name

Lightwalker ST-E ADVANCED

Version/Model Number

M002-6A/2 ADVANCED

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

-

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

40d2701e-e134-4bdc-a77c-b97917139a3e

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FOTONA D.O.O." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 27