Catalog Number

-

Brand Name

Q-Switched Nd:YAG Laser

Version/Model Number

Q10

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

K171079

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

e9e7c5bd-812e-4160-a140-a6a7f17f0f95

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

June 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-