Product code QPE

Device name

Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4880

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

This device consists of a light emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics.

Source

FDA openFDA device classification dataset