Catalog Number

-

Brand Name

Powered Laser Surgical Instrument-Diode Laser Model

Version/Model Number

DLH-06

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

K123483

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

4f8c366d-bb7d-4040-b446-d20909e394ed

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

June 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-