Probe, 405 Blue-Vio, labeled, US - The Scalar Wave Laser System is indicated for - STELLAR LASERS LLC

Duns Number:063416211

Device Description: The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint p The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

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More Product Details

Catalog Number

-

Brand Name

Probe, 405 Blue-Vio, labeled, US

Version/Model Number

600140

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K091158

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

a5a35425-fab7-479e-8ec8-785412dff55e

Public Version Date

January 08, 2019

Public Version Number

4

DI Record Publish Date

February 11, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STELLAR LASERS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5