Duns Number:621560338
Device Description: Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments (Continuous Wave - CW power 28W and Intense Super Pulse - ISP power 30W) are in the form of non-ionizing radiation in which the invisible light wave doses (810nm +/- 10nm, 915nm +/- 10nm, 980nm +/- 10nm) and visible light wave aiming beam (650nm +/- 20nm) are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
Catalog Number
SLP4H
Brand Name
Platinum
Version/Model Number
P4H
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
10ab7ef1-5bda-4fa1-8a2d-9a7d4111e10e
Public Version Date
October 05, 2022
Public Version Number
31
DI Record Publish Date
October 27, 2020
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. | 9 |