Cleared Traditional

K210077 - MED RF 4000 (FDA 510(k) Clearance)

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

K210077 · F Care Systems USA, LLC · General & Plastic Surgery device
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Dec 2021
Decision
339d
Days
Class 2
Risk

K210077 is an FDA 510(k) clearance for the MED RF 4000. Classified as Electrosurgical Coagulation For Aesthetic (product code ONQ), Class II - Special Controls.

Submitted by F Care Systems USA, LLC (Miami, US). The FDA issued a Cleared decision on December 17, 2021 after a review of 339 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: Standard predicate-based submission. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K210077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2021
Decision Date December 17, 2021
Days to Decision 339 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
225d slower than avg
Panel avg: 114d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONQ Electrosurgical Coagulation For Aesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition For The Treatment Of Spider Vein Or Telangiectasia By Thermocoagulation.
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.