reVive Light Therapy® - LED TECHNOLOGIES INC

Duns Number:197386191

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More Product Details

Catalog Number

-

Brand Name

reVive Light Therapy®

Version/Model Number

RVGLOAC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

OLP

Product Code Name

Over-The-Counter Powered Light Based Laser For Acne

Device Record Status

Public Device Record Key

3f145135-ca82-438d-ac6f-4c70e2209369

Public Version Date

August 13, 2020

Public Version Number

1

DI Record Publish Date

August 05, 2020

Additional Identifiers

Package DI Number

B347RVGLOAC1

Quantity per Package

24

Contains DI Package

B347RVGLOAC0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"LED TECHNOLOGIES INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 49