Catalog Number

-

Brand Name

Vbeam Prima Base Laser System, JP

Version/Model Number

9914-KK-9081

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

K183452

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

15a39e16-94c1-4419-a580-db83d0dc98a6

Public Version Date

October 12, 2022

Public Version Number

2

DI Record Publish Date

January 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-