Currentbody Skin LED Light Therapy Mask - V1 facemask- Currentbody Skin Branded - I-SMART DEVELOPMENTS LIMITED

Duns Number:223616320

Device Description: V1 facemask- Currentbody Skin Branded

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More Product Details

Catalog Number

111A

Brand Name

Currentbody Skin LED Light Therapy Mask

Version/Model Number

TN2010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K191629

Product Code Details

Product Code

OHS

Product Code Name

Light Based Over The Counter Wrinkle Reduction

Device Record Status

Public Device Record Key

4dfd4ad1-ff19-4bd4-9d66-958634136af8

Public Version Date

December 09, 2021

Public Version Number

2

DI Record Publish Date

May 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"I-SMART DEVELOPMENTS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 29