DeviceClearance

Product code QPE— General, Plastic Surgery

Klox Biophotonic LumiHeal System

Classification name
Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions
Device class
Class 2
Regulation
21 CFR 878.4880
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QPE under 21 CFR 878.4880, via openFDA

Market context for product code QPE

FDA has cleared 1 device under product code QPE, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QPE

Recent clearances under product code QPE

Data sourced from openFDA. This site is unofficial and independent of the FDA.