Catalog Number

APYX-150B

Brand Name

Renuvion®/J-Plasma®

Version/Model Number

APYX-150B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

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

K183610

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

f8eb418d-0f41-41e1-9a51-f0e056d6af47

Public Version Date

May 14, 2021

Public Version Number

3

DI Record Publish Date

March 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-