Cleared Traditional

K191940 - Palm NRG cellulite and muscle toning bo...

K191940 is the FDA 510(k) clearance for Palm NRG cellulite and muscle toning bo... by Heat IN A Click. It is a Class 2 General & Plastic Surgery device (product code PBX) cleared through the Traditional 510(k) pathway after a 473-day FDA review.

K191940 · Heat IN A Click · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
473d
Days
Class 2
Risk

K191940 is an FDA 510(k) clearance for the Palm NRG cellulite and muscle toning body device. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Heat IN A Click (Homestead, US). The FDA issued a Cleared decision on November 3, 2020 after a review of 473 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 Heat IN A Click devices

Submission Details

510(k) Number K191940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2019
Decision Date November 03, 2020
Days to Decision 473 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
358d slower than avg
Panel avg: 115d · This submission: 473d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Guangzhou GLOMED Biological Technology Co., Ltd.
Cassie Lee

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.

Regulatory Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

All 60
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K191940.
Evolve System with the T3 Applicator
K210877 · Inmode , Ltd. · Jul 2021
NuEra Tight RF, NuEra Tight RF Plus
K210867 · Bios S.R.L. · Apr 2021
V30 system, V20 system, V10 system, V-VR Hand piece
K202247 · Viora , Ltd. · Dec 2020
Ultimate Contour, Ultimate Contour Mini
K201475 · CAO Group, Inc. · Oct 2020
NuEra Tight, NuEra Tight EMS
K200359 · Bios S.R.L. · Aug 2020
V30 System, V20 System, V10 System, V-FR Handpiece
K201064 · Viora , Ltd. · Jul 2020