Not Cleared Direct

DEN200005 - Klox Biophotonic LumiHeal System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200005 · Klox Technlogies, Inc. · General & Plastic Surgery device
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Dec 2021
Decision
668d
Days
Class 2
Risk

DEN200005 is an FDA 510(k) submission (not cleared) for the Klox Biophotonic LumiHeal System. Classified as Phototherapy Device For Reducing The Appearance Of Acute Post-surgical Incisions (product code QPE), Class II - Special Controls.

Submitted by Klox Technlogies, Inc. (Laval, CA). The FDA issued a Not Cleared (DENG) decision on December 3, 2021 after a review of 668 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4880 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 668 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Klox Technlogies, Inc. devices

Submission Details

510(k) Number DEN200005 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 04, 2020
Decision Date December 03, 2021
Days to Decision 668 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
554d slower than avg
Panel avg: 114d · This submission: 668d
Pathway characteristics

Device Classification

Product Code QPE Phototherapy Device For Reducing The Appearance Of Acute Post-surgical Incisions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4880
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.