Catalog Number

-

Brand Name

SpectraLite

Version/Model Number

BA567010

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)

-

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

7b5ac0b6-f47b-4d68-83cb-b4f37a2556b3

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

January 23, 2017

Package DI Number

B347BA5670102

Quantity per Package

8

Contains DI Package

B347BA5670101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-