Catalog Number

864NL0048MMCT

Brand Name

DAAVLIN

Version/Model Number

NEOLUX MM CT

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153749

Product Code

FTC

Product Code Name

Light, Ultraviolet, Dermatological

Public Device Record Key

b07867eb-03ec-4044-843e-91428badc10e

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-