QPE

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

Product code: QPE
Device name: Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions
Device class: Class 2
21 CFR: 21 CFR 878.4880
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QPE

Classification and pathway per current FDA publications. Data from openFDA (CC0).