Catalog Number

13752

Brand Name

Skin Renu Laser

Version/Model Number

SRL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130459

Product Code

ONG

Product Code Name

Powered Laser Surgical Instrument With Microbeam\Fractional Output

Public Device Record Key

f85e3cfd-d46b-4af2-8c9d-e8f00f8c30f0

Public Version Date

May 24, 2021

Public Version Number

2

DI Record Publish Date

July 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-