Cleared Traditional

K161941 - Pulsaderm Acne Device

K161941 is an FDA 510(k) clearance for Pulsaderm Acne Device, manufactured by Nutra Luxe MD, LLC. The device is a Class 2 General & Plastic Surgery device with product code OLP cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K161941 · Nutra Luxe MD, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
96d
Days
Class 2
Risk

K161941 is an FDA 510(k) clearance for the Pulsaderm Acne Device. Classified as Over-the-counter Powered Light Based Laser For Acne (product code OLP), Class II - Special Controls.

Submitted by Nutra Luxe MD, LLC (Fort Myers, US). The FDA issued a Cleared decision on October 19, 2016 after a review of 96 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K161941

510(k) Number K161941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2016
Decision Date October 19, 2016
Days to Decision 96 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
19d faster than avg
Panel avg: 115d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLP Device Classification - Class 2, Special Controls

Product Code OLP Over-the-counter Powered Light Based Laser For Acne
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris.
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 - OLP Over-the-counter Powered Light Based Laser For Acne

All 50
Devices cleared under the same product code (OLP) and FDA review panel - the closest regulatory comparables to K161941.
LED Phototherapy Device
K162098 · Li-Tek Electronic Technology Corporation · Jan 2017
Pulsaderm ACE-All Blue
K162371 · Nutra Luxe MD, LLC · Dec 2016
ESPADA Acne-Clearing Blue Light Pen
K162450 · Foreo, Inc. · Nov 2016
Acne Light Therapy Wand
K160691 · Zuko, Inc. · Jun 2016
Tria Sapphire
K160821 · Tria Beauty, Inc. · Jun 2016
Clear Bi-Light
K153081 · Michael Todd, LP · Feb 2016