Cleared Traditional

K162371 - Pulsaderm ACE-All Blue

K162371 is an FDA 510(k) clearance for Pulsaderm ACE-All Blue, 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 113-day FDA review.

K162371 · 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
Dec 2016
Decision
113d
Days
Class 2
Risk

K162371 is an FDA 510(k) clearance for the Pulsaderm ACE-All Blue. 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 Meyers, US). The FDA issued a Cleared decision on December 15, 2016 after a review of 113 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 - K162371

510(k) Number K162371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2016
Decision Date December 15, 2016
Days to Decision 113 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
2d faster than avg
Panel avg: 115d · This submission: 113d
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 K162371.
Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37
K170111 · Pulsaderm, LLC · May 2017
BC-001+ Acne Purifier
K170260 · Oriental Inspiration Limited · Apr 2017
LED Phototherapy Device
K162098 · Li-Tek Electronic Technology Corporation · Jan 2017
ESPADA Acne-Clearing Blue Light Pen
K162450 · Foreo, Inc. · Nov 2016
Pulsaderm Acne Device
K161941 · Nutra Luxe MD, LLC · Oct 2016
Acne Light Therapy Wand
K160691 · Zuko, Inc. · Jun 2016