Cleared Special

K182094 - Family of Venus RF Systems - Heal (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182094 · Venus Concept USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
182d
Days
Class 2
Risk

K182094 is an FDA 510(k) clearance for the Family of Venus RF Systems - Heal. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Venus Concept USA, Inc. (Weston, US). The FDA issued a Cleared decision on February 1, 2019 after a review of 182 days - an extended review 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Venus Concept USA, Inc. devices

Submission Details

510(k) Number K182094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2018
Decision Date February 01, 2019
Days to Decision 182 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 114d · This submission: 182d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PBX Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite.
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 Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

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