Platinum LED Therapy Lights - BIOMAX600 - PLATINUM LED HOLDINGS LLC

Duns Number:024319954

Device Description: BIOMAX600

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More Product Details

Catalog Number

BIOMAX600

Brand Name

Platinum LED Therapy Lights

Version/Model Number

BIOMAX600

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

-

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

49301a53-d465-4c92-b8cd-b9f3eff8d7e6

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

June 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PLATINUM LED HOLDINGS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16