Catalog Number

3503

Brand Name

Smooth Beauty Eye Wrinkle Laser

Version/Model Number

FANp

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

K141868

Product Code

ONG

Product Code Name

Powered Laser Surgical Instrument With Microbeam\Fractional Output

Public Device Record Key

cc8f4ede-bc2e-4183-8a34-860e256f114c

Public Version Date

May 24, 2021

Public Version Number

4

DI Record Publish Date

January 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-