Duns Number:364134791
Device Description: Del Sol Red Cordless LED Light for EU/CE only
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
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
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
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
Package DI Number
00850043007357
Quantity per Package
1
Contains DI Package
00850043007340
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |