Catalog Number

1614-01

Brand Name

LightStim & HydraFacial Elipsa

Version/Model Number

Elipsa Black

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OHS

Product Code Name

Light Based Over The Counter Wrinkle Reduction

Public Device Record Key

9357abba-c81e-469c-a3a4-751cbef23e13

Public Version Date

March 15, 2022

Public Version Number

1

DI Record Publish Date

March 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-