Catalog Number

864NL4800X

Brand Name

DAAVLIN

Version/Model Number

NEOLUX X

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

f9a61a95-2cf4-4e1d-8b7f-b96b02c22d8a

Public Version Date

December 21, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-