Product code QCR

Device name

Wound Autofluorescence Imaging Device

Medical specialty

General, Plastic Surgery

Device class

1

Regulation number

878.4165

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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.

Source

FDA openFDA device classification dataset