Catalog Number

-

Brand Name

Nd Yag Q-Switch Laser Therapy Machine

Version/Model Number

FG 2010-C

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

K161926

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

00a71d3e-573e-439e-901a-41a0a2e578cc

Public Version Date

September 07, 2022

Public Version Number

1

DI Record Publish Date

August 30, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-