Cleared Traditional

K170111 - Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170111 · Pulsaderm, LLC · General & Plastic Surgery device
May 2017
Decision
116d
Days
Class 2
Risk

K170111 is an FDA 510(k) clearance for the Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37. Classified as Over-the-counter Powered Light Based Laser For Acne (product code OLP), Class II - Special Controls.

Submitted by Pulsaderm, LLC (Fort Myers, US). The FDA issued a Cleared decision on May 8, 2017 after a review of 116 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.

Submission Details

510(k) Number K170111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2017
Decision Date May 08, 2017
Days to Decision 116 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 132d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.