DEKA HIRO 3.0 - The ASA LASER HIRO 3.0 device is a medical device - EL.EN. SPA

Duns Number:436887608

Device Description: The ASA LASER HIRO 3.0 device is a medical device for carrying out therapy in the treatmen The ASA LASER HIRO 3.0 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG Laser source.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

M080K1

Brand Name

DEKA HIRO 3.0

Version/Model Number

M080K1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051537

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

bdec5bb0-fab3-4dbf-91dd-dd03b44b4506

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EL.EN. SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 46