Duns Number:554165991
Device Description: Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
Catalog Number
-
Brand Name
Dimed
Version/Model Number
CHERYLAS-15N
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
a74db7da-84df-44e4-b19e-7ad18734a5de
Public Version Date
March 10, 2021
Public Version Number
1
DI Record Publish Date
March 02, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 20 |