Cleared Traditional

K213247 - JETT PLASMA Medical II (FDA 510(k) Clearance)

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

K213247 · Compex, Spol, S.R.O. · General & Plastic Surgery device
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Mar 2023
Decision
530d
Days
Class 2
Risk

K213247 is an FDA 510(k) clearance for the JETT PLASMA Medical II. Classified as Low Power Electrosurgical Devices For Skin Lesion Destruction (product code QVJ), Class II - Special Controls.

Submitted by Compex, Spol, S.R.O. (Brno, CZ). The FDA issued a Cleared decision on March 14, 2023 after a review of 530 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 Compex, Spol, S.R.O. devices

Submission Details

510(k) Number K213247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2021
Decision Date March 14, 2023
Days to Decision 530 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
416d slower than avg
Panel avg: 114d · This submission: 530d
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

Medical Device Academy, Inc.
Robert V Packard

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.