Duns Number:202128257
Device Description: The MedX SLD Light Cluster accessory, MCT 1001, offers SLD light therapy for broader appli The MedX SLD Light Cluster accessory, MCT 1001, offers SLD light therapy for broader applications. This accessory can be strapped to the body for “hands-free”, unattended treatment. The accessory contains a large number of Light emitting diodes that are used to treat a variety of medical conditions such as swelling, inflammation, pain, bruising, wound healing and many other medical conditions.This laser medical device accessory is controlled and powered by MBM 1100N. This product is registered for the purpose of having a UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.
Catalog Number
-
Brand Name
MedX SLD Light Cluster
Version/Model Number
1001
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
K032231,K032231,K032231
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
3c9010fb-81a9-4fc8-8950-1c86d4dbeb9b
Public Version Date
May 07, 2019
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
20628451918299
Quantity per Package
2
Contains DI Package
00628451918295
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shippng carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |