Wound Autofluorescence Imaging Device

Who Makes This Device Type in China?

One manufacturer in China holds an FDA registration for this device type, based in Jiangsu. All of them are contract manufacturers, able to build to a buyer’s own specification.

Exact Medical Manufacturing, Inc. Jiangsu, contract manufacturer

What Is This Device?

A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.

How Is QCR Classified?

Wound Autofluorescence Imaging Device is FDA product code QCR, Class 1, 21 CFR 878.4165.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Wound Autofluorescence Imaging Device

Ray 1

Ray 1 is a portable hyperspectral imaging tool that allows qualified healthcare professionals, to assess wounds, at the point of care: i) to capture and digitally record images of…

Wound Autofluorescence Imaging Device

LED Daylite Reveal

The REVEAL FC is indicated for use as a wound autofluorescence imaging device to view autofluorescence images from skin wounds that are exposed to its excitation light.

Wound Autofluorescence Imaging Device

Who Makes This Device Type in China?

What Is This Device?

How Is QCR Classified?

What Does It Take to Sell It in the United States?

Ray 1

LED Daylite Reveal

Where China Actually Supplies