Catalog Number

-

Brand Name

PicoWay Laser System

Version/Model Number

9914-JB-9060

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191685

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

0a3c6aaa-d898-401c-89b1-db8b2dd6a75a

Public Version Date

October 12, 2022

Public Version Number

2

DI Record Publish Date

April 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-