The ZIONIC PRO MAX (radiofrequency) equipment when used with the capacitive or resistive handpiece is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.

Device Description

The Zionic Pro Max with Radiofrequency is a non-invasive topical heating device that produces RF energy to warm subcutaneous tissue the therapeutic temperature of 40-45°C. The device includes two different type of RF handpieces, resistive and capacitive, which are connected to a console and software-powered user interface. The Zionic Pro Max adds a new capacitive handpiece and user interface to a previously cleared generation of the device.

AI/ML Overview

The provided FDA 510(k) clearance letter for the Zionic Pro Max (Radiofrequency) device primarily concerns the safety and effectiveness of a medical device intended for topical heating and reduction of cellulite. It is not an AI/ML device that deals with image analysis, diagnosis, or prediction, and therefore, many of the typical acceptance criteria and study details associated with AI/ML medical devices (like MRMC studies, ground truth establishment by experts, sample sizes for training/test sets in the context of machine learning, etc.) are not applicable to this document.

The document discusses performance testing in the context of electrical safety, electromagnetic compatibility, and the device's ability to achieve and maintain a specific tissue temperature. It does not involve any AI/ML components requiring complex ground truth adjudication or studies for human-in-the-loop performance improvement.

Therefore, I will extract relevant information that is present in the document pertaining to the device's performance criteria and how it was shown to meet them.

Acceptance Criteria and Reported Device Performance

The core performance criterion for the Zionic Pro Max device, as established through non-clinical testing, is its ability to heat tissue to a specific therapeutic temperature.

Acceptance Criteria	Reported Device Performance
Maintain tissue temperature for topical heating	Demonstrated ability to maintain a tissue temperature of 40-45°C for 10 minutes of treatment.
Accuracy of output power	Bench testing performed to demonstrate accuracy.
Accuracy of output frequency	Bench testing performed to demonstrate accuracy.
Accuracy of output voltage	Bench testing performed to demonstrate accuracy.
Electrical Safety	Complied with IEC 60601-1 Edition 3.2 2020-08.
Electromagnetic Compatibility (EMC)	Complied with IEC 60601-1-2:2014 + A1:2020.
Safety and performance of High-Frequency Surgical Equipment	Complied with IEC 60601-2-2:2017.
Software Life Cycle Processes	Complied with IEC 62304:2006+A1:2015.
Application of Risk Management	Complied with EN ISO 14971:2019+A11:2021.

Study Details (Based on available information in the 510(k) Summary)

Since this is not an AI/ML device, the standard questions regarding AI/ML study design (such as data provenance, expert ground truth establishment for diagnostic performance, MRMC studies, training set details) are not directly addressed in this type of 510(k) summary. The "study" here refers to non-clinical, benchtop performance testing to ensure the device meets its physical and electrical specifications and performs its intended function (heating tissue) effectively and safely.

Sample size used for the test set and the data provenance:
- The document mentions "Tissue thermal testing" and "Bench testing" but does not specify the sample size (e.g., number of test repetitions, number of ex-vivo tissue samples, or number of devices tested).
- Data Provenance: Not specified, but generally, bench testing data would be generated in a lab setting, likely by the manufacturer (TermoSalud S.L.) or a contracted testing facility. No indication of patient data or country of origin for such data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this device's performance is determined by physical measurements (temperature, power, frequency, voltage) using calibrated equipment, not by expert interpretation of complex visuals or medical conditions. Therefore, no human experts are mentioned for establishing ground truth in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human experts are interpreting complex data (e.g., medical images) and their decisions need to be reconciled. This device's testing involves objective physical measurements.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is hardware for topical heating and cellulite reduction, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not have a standalone algorithm in the sense of an AI/ML component performing diagnostic tasks. Its "performance" is based on the physical output and safety of the radiofrequency energy. The "software" mentioned (IEC 62304) relates to the control unit's functionality, not an AI/ML diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical testing appears to be measured physical parameters (e.g., temperature attained, electrical output values) against predefined specifications (40-45°C, accurate power/frequency/voltage).
The sample size for the training set:
- Not applicable. There is no indication of a machine learning model being trained with a dataset mentioned in this 510(k) document. The "training" here refers to manufacturing and operational parameters, not data for an AI algorithm.
How the ground truth for the training set was established:
- Not applicable. As there is no mention of an ML training set, there's no ground truth establishment method for it.

In summary, the provided document details the regulatory clearance for a physical medical device (radiofrequency equipment) based on its direct electrical and thermal performance characteristics, not on the performance of a software algorithm leveraging a dataset of medical cases.

Summary

FDA 510(k) Clearance Letter - Zionic Pro Max (Radiofrequency)

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov

May 28, 2025

TermoSalud S.L.
℅ Aubrey Thompson
Regulatory Consultant
Hoy and Associates Regulatory Consulting
1830 Bonnie Way
Sacramento, California 95825

Re: K243716
Trade/Device Name: Zionic Pro Max (Radiofrequency)
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories
Regulatory Class: Class II
Product Code: PBX
Dated: April 25, 2025
Received: April 25, 2025

Dear Aubrey Thompson:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

May 28, 2025

TermoSalud S.L.
℅ Aubrey Thompson
Regulatory Consultant
Hoy and Associates Regulatory Consulting
1830 Bonnie Way
Sacramento, California 95825

Dear Aubrey Thompson:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K243716 - Aubrey Thompson Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K243716 - Aubrey Thompson Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James H. Jang -S Digitally signed by James H. Jang -S Date: 2025.05.28 18:52:23 -04'00'

James Jang, Ph.D.
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K243716

Device Name
Zionic ProMax (radiofrequency)

Indications for Use (Describe)
The ZIONIC PRO MAX (radiofrequency) equipment when used with the capacitive or resistive handpiece is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K243716

Device Name
Zionic ProMax (radiofrequency)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

510(K) Summary

ZIONIC PRO MAX – RF

K243716

Applicant: TermoSalud

Address: Ataulfo Friera Tarfe, 8 -33211 Gijón, Spain

Contact Person: Aubrey Thompson, Regulatory Consultant

Contact Information: aubreythompson@hoyregulatory.com

Preparation Date: May 27, 2025

Device Trade Name: ZIONIC Pro Max with Radiofrequency

Common Name: Massager, vacuum, radio frequency induced heat

Regulation Number: 878.4400

Product Code: PBX

Regulatory Class: II

Legally Marketed Predicate: Symmed Elite Aesthetic (K230412)

Legally Marketed Reference: Zionic Aesthetic (K230659)

Device Description:

Indications for use:

510(K) Summary

ZIONIC PRO MAX – RF

K243716

Applicant: TermoSalud

Address: Ataulfo Friera Tarfe, 8 -33211 Gijón, Spain

Contact Person: Aubrey Thompson, Regulatory Consultant

Contact Information: aubreythompson@hoyregulatory.com

Preparation Date: May 27, 2025

Device Trade Name: ZIONIC Pro Max with Radiofrequency

Common Name: Massager, vacuum, radio frequency induced heat

Regulation Number: 878.4400

Product Code: PBX

Regulatory Class: II

Legally Marketed Predicate: Symmed Elite Aesthetic (K230412)

Legally Marketed Reference: Zionic Aesthetic (K230659)

Device Description:

Indications for use:

Page 6

510(K) Summary

ZIONIC PRO MAX – RF

K243716

Indications for Use Comparison

Specification	Zionic Pro Max	Predicate Device Symmed Elite Aesthetic	Reference Device Zionic Aesthetic	Comparison
Indications for use	The ZIONIC PRO MAX (radiofrequency) equipment when used with the capacitive or resistive handpiece is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.	The Symmed Elite Aesthetic is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.	The Zionic Aesthetic equipment is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.	The topical heating and temporary reduction in the appearance of cellulite indications for use are identical to the predicate and reference devices.

510(K) Summary

ZIONIC PRO MAX – RF

K243716

Indications for Use Comparison

Specification	Zionic Pro Max	Predicate Device Symmed Elite Aesthetic	Reference Device Zionic Aesthetic	Comparison
Indications for use	The ZIONIC PRO MAX (radiofrequency) equipment when used with the capacitive or resistive handpiece is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.	The Symmed Elite Aesthetic is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.	The Zionic Aesthetic equipment is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.	The topical heating and temporary reduction in the appearance of cellulite indications for use are identical to the predicate and reference devices.

Page 7

510(K) Summary

ZIONIC PRO MAX – RF

K243716

Technical Specifications Comparison

Specification	Subject Device Zionic Pro Max with RF	Predicate Device Symmed Elite Aesthetic	Reference Device Zionic Aesthetic	Comparison
Mode of operation	Non-invasive monopolar radiofrequency	Non-invasive monopolar radiofrequency	Non-invasive monopolar radiofrequency	Same
RF output frequency	470KHz	448 kHz +/- 10%	N/A	Different. The Zionic Pro Max RF device's output frequency is slightly higher than the predicate device.
Capacitive RF output max power	200W	500VA	N/A	Different. But the performance testing demonstrates effectiveness.
Resistive RF output power	200W	200W	200W	Same
Electrode area	57mm/90mm	70mm/50mm/30mm	57/90mm	Different. The subject device has a larger electrode but the tissue thermal testing demonstrated equivalence to the predicate.

510(K) Summary

ZIONIC PRO MAX – RF

K243716

Technical Specifications Comparison

Specification	Subject Device Zionic Pro Max with RF	Predicate Device Symmed Elite Aesthetic	Reference Device Zionic Aesthetic	Comparison
Mode of operation	Non-invasive monopolar radiofrequency	Non-invasive monopolar radiofrequency	Non-invasive monopolar radiofrequency	Same
RF output frequency	470KHz	448 kHz +/- 10%	N/A	Different. The Zionic Pro Max RF device's output frequency is slightly higher than the predicate device.
Capacitive RF output max power	200W	500VA	N/A	Different. But the performance testing demonstrates effectiveness.
Resistive RF output power	200W	200W	200W	Same
Electrode area	57mm/90mm	70mm/50mm/30mm	57/90mm	Different. The subject device has a larger electrode but the tissue thermal testing demonstrated equivalence to the predicate.

Page 8

510(K) Summary

ZIONIC PRO MAX – RF

K243716

Performance Testing

Verification and validation activities were successfully completed and establish that the ZIONIC Pro Max control unit performs as intended. Testing included the following:

60601-1 Edition 3.2 2020-08; Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-1-2:2014 + A1:2020; Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests;
IEC 60601-2-2:2017; Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories;
IEC 62304:2006+A1:2015; Medical Device – Software Life Cycle Processes;
EN ISO 14971:2019+A11:2021; Medical Devices – Application Of Risk Management To Medical Devices

Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

Non-Clinical Testing

Tissue thermal testing was performed to demonstrate that the device can maintain a temperature of 40-45°C for 10 minutes of treatment. Bench testing was performed to demonstrate the accuracy of the output power, output frequency, and output voltage.

Conclusion

The ZIONIC Pro Max (subject device) and the Symmed Elite Aesthetic (predicate device) have identical indications for use. The Zionic Pro Max has a different capacitive maximum than the predicate which does not impact safety or efficacy of the device. The Zionic Pro Max includes electrodes that are coated (capacitive) and uncoated (resistive), while the predicate only has the resistive electrodes. The Capacitive and Resistive electrodes have different methods of generating heat, but the mechanism of action (topical heating) is the same and performance testing demonstrates that they perform the same, maintaining a tissue temperature of 40°C for 10 minutes of treatment, the same as the predicate device. The indications for use, functionality, type and design of electrodes, skin temperature sensing of the Zionic Pro Max are similar to or the same as the legally marketed predicate device. Performance and non-clinical testing conducted on the device demonstrates that the performance is as safe and effective, and performs as well as the legally marketed predicate device for requested indications for use and therefore is substantially equivalent to the predicate device.

510(K) Summary

ZIONIC PRO MAX – RF

K243716

Performance Testing

Verification and validation activities were successfully completed and establish that the ZIONIC Pro Max control unit performs as intended. Testing included the following:

60601-1 Edition 3.2 2020-08; Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-1-2:2014 + A1:2020; Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests;
IEC 60601-2-2:2017; Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories;
IEC 62304:2006+A1:2015; Medical Device – Software Life Cycle Processes;
EN ISO 14971:2019+A11:2021; Medical Devices – Application Of Risk Management To Medical Devices

Non-Clinical Testing

Conclusion

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.