Catalog Number

70392-01

Brand Name

Del Sol Blue Light Therapy System

Version/Model Number

Cordless (EU)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K061470,K061470

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

17da3726-0dd9-406e-905c-f68c8cfbdc5c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 03, 2017

Package DI Number

00850043007364

Quantity per Package

1

Contains DI Package

00850043007371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box