Dimed - Therapy Laser System, with Product Code of ILY, - Wuhan Dimed Laser Technology Co., Ltd.

Duns Number:554165991

Device Description: Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)

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More Product Details

Catalog Number

-

Brand Name

Dimed

Version/Model Number

BERYLAS-15J

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

-

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

3879d1a0-04b9-4b98-bc4f-6ad494681b8d

Public Version Date

March 10, 2021

Public Version Number

1

DI Record Publish Date

March 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WUHAN DIMED LASER TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20