510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200005Unknown

Klox Biophotonic LumiHeal System

Klox Technlogies, Inc., Laval, CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN200005 is the FDA 510(k) clearance record for Klox Biophotonic LumiHeal System, a class II device, cleared for Klox Technlogies, Inc. on under FDA product code QPE (Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions). FDA's definition for product code QPE reads: "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...". FDA records list one 510(k) clearance for Klox Technlogies, Inc. As of , FDA records show no recalls naming DEN200005.

Clearance record

Decision date
Received
(668 days to decision)
Product code
QPE Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions
Regulation
21 CFR 878.4880
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Klox Technlogies, Inc. 275, Boul. Armand Frappier, Laval, CA
Third party review
No

Clearances, product code QPE

Trailing 12 months

FDA records hold no clearances under product code QPE in the trailing twelve months.

FDA records show no clearances under product code QPE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QPE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260