Cleared Traditional

K173436 - Luma Light System

K173436 is the FDA 510(k) clearance for Luma Light System by Luma Therapeutics. It is a Class 2 General & Plastic Surgery device (product code FTC) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K173436 · Luma Therapeutics · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
88d
Days
Class 2
Risk

K173436 is an FDA 510(k) clearance for the Luma Light System. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Luma Therapeutics (Millbrae, US). The FDA issued a Cleared decision on January 30, 2018 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4630 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Luma Therapeutics devices

Submission Details

510(k) Number K173436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2017
Decision Date January 30, 2018
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTC Light, Ultraviolet, Dermatological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4630
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.

Regulatory Peers - FTC Light, Ultraviolet, Dermatological

All 24
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K173436.
UV Phototherapy
K181805 · Xuzhou Kernel Medical Equipment Co., Ltd. · Jan 2019
ClearLink Controlled Phototherapy Equipment
K182215 · Daavlin Distributing Company · Oct 2018
308nm Excimer System
K172273 · Chongqing Peninsula Medical Technology Co., Ltd. · Jul 2018
CYNOSUREA ECLILITE AND ECLILITE U
K050080 · Cynosure, Inc. · May 2005