Duns Number:202128257
Device Description: The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Lev The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals.
Catalog Number
-
Brand Name
MedX Rehab Portable Laser
Version/Model Number
0915
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,K032231,K032231,K032231,K032231
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
c34242f6-b36e-4719-9397-561c98d1a6e6
Public Version Date
May 07, 2019
Public Version Number
10
DI Record Publish Date
September 24, 2016
Package DI Number
70628451918232
Quantity per Package
7
Contains DI Package
00628451918233
Package Discontinue Date
February 27, 2019
Package Status
Not in Commercial Distribution
Package Type
brown shipping carto
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |