Cleared Traditional

K220493 - Plaxpot Multi Plasma (FDA 510(k) Clearance)

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

K220493 · Gcs Co. Limited · General & Plastic Surgery device
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Oct 2023
Decision
612d
Days
Class 2
Risk

K220493 is an FDA 510(k) clearance for the Plaxpot Multi Plasma. Classified as Low Power Electrosurgical Devices For Skin Lesion Destruction (product code QVJ), Class II - Special Controls.

Submitted by Gcs Co. Limited (Seongnam, KR). The FDA issued a Cleared decision on October 27, 2023 after a review of 612 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Gcs Co. Limited devices

Submission Details

510(k) Number K220493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2022
Decision Date October 27, 2023
Days to Decision 612 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
498d slower than avg
Panel avg: 114d · This submission: 612d
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

Compliance Insight
Su Kyung Park

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.