Cleared Traditional

K223440 - Plasma Pen (Plasma MD) (FDA 510(k) Clearance)

Also includes:
Plasma Pen (Plasma +)

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

K223440 · Plasma Concepts · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
108d
Days
Class 2
Risk

K223440 is an FDA 510(k) clearance for the Plasma Pen (Plasma MD). Classified as Low Power Electrosurgical Devices For Skin Lesion Destruction (product code QVJ), Class II - Special Controls.

Submitted by Plasma Concepts (Woburn, US). The FDA issued a Cleared decision on March 2, 2023 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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.

View all Plasma Concepts devices

Submission Details

510(k) Number K223440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2022
Decision Date March 02, 2023
Days to Decision 108 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
6d faster than avg
Panel avg: 114d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QVJ Low Power Electrosurgical Devices For Skin Lesion Destruction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition For The Removal And Destruction Of Skin Lesions In General Dermatological Procedures, Also Referred To As Plasma Pen Devices, Which Generates Electrical Arc In The Ambient Air Between An Electrical Probe Tip And The Skin And Cause Intended Tissue Damage For The Removal And Destruction Of Skin Lesions
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 Consultant

Medicept, LLC
Richelle Helman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.