Poly Spot - Handheld LED Light Therapy Device. Treatment - Medtek Lighting Corporation

Duns Number:002692106

Device Description: Handheld LED Light Therapy Device. Treatment heads, available in Blue (415nm) or Red (633n Handheld LED Light Therapy Device. Treatment heads, available in Blue (415nm) or Red (633nm), help to mitigate a variety of skin conditions.There are 8 LEDs to provide a treatment area of 4 sq. cm. Batery powered with a charger

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More Product Details

Catalog Number

-

Brand Name

Poly Spot

Version/Model Number

7000C2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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

PWC

Product Code Name

General Wellness Product

Device Record Status

Public Device Record Key

ea76ccd1-bcf6-48de-9214-92d6c7d16caa

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

September 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTEK LIGHTING CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21
U Unclassified 3