Del Sol Red Light Therapy System - Del Sol Red Cordless LED Light for EU/CE only - EDGE SYSTEMS LLC

Duns Number:364134791

Device Description: Del Sol Red Cordless LED Light for EU/CE only

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More Product Details

Catalog Number

70393-01

Brand Name

Del Sol Red Light Therapy System

Version/Model Number

Cordless (EU)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K072399,K072399

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

902fff92-3ccf-4592-80b6-8f191efb2240

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

July 03, 2017

Additional Identifiers

Package DI Number

00850043007357

Quantity per Package

1

Contains DI Package

00850043007340

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"EDGE SYSTEMS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8