Cleared Traditional

K233760 - Mjolnir Pro. (Multi–electrode plasma) (FDA 510(k) Clearance)

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

K233760 · Shenzhen Leaflife Technology Co., Ltd. · General & Plastic Surgery device
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Feb 2024
Decision
88d
Days
Class 2
Risk

K233760 is an FDA 510(k) clearance for the Mjolnir Pro. (Multi–electrode plasma). Classified as Low Power Electrosurgical Devices For Skin Lesion Destruction (product code QVJ), Class II - Special Controls.

Submitted by Shenzhen Leaflife Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 20, 2024 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Leaflife Technology Co., Ltd. devices

Submission Details

510(k) Number K233760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2023
Decision Date February 20, 2024
Days to Decision 88 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
26d faster than avg
Panel avg: 114d · This submission: 88d
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.