(91 days)
Not Found
No
The summary describes a resistive radiofrequency device with rolling electrodes for massage and heating. There is no mention of AI, ML, image processing, or any data-driven learning components in the device description, intended use, or performance studies.
Yes
The device is intended to treat specific medical conditions, such as temporary relief of pain and muscle spasms, and to increase local circulation, which falls under the definition of a therapeutic device.
No
Explanation: The "Intended Use/Indications for Use" section states that the device is intended for "topical heating" and "massage" to treat certain medical conditions and reduce the appearance of cellulite, not to diagnose a condition.
No
The device description explicitly states it is a "resistive radiofrequency device" with "two different electrodes" and a "control unit," indicating it is a hardware device that utilizes software for control and operation, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Zionic Aesthetic's Intended Use: The Zionic Aesthetic is intended for topical heating and massage applied directly to the body for therapeutic purposes (pain relief, muscle spasms, circulation, cellulite reduction). It does not involve the analysis of specimens taken from the body.
- Device Description: The device description clearly states it's a resistive radiofrequency device with electrodes that roll on the skin. This is consistent with a physical therapy or aesthetic device, not an IVD.
- Lack of IVD-related information: The document does not mention any aspects related to specimen collection, analysis, or diagnostic results, which are hallmarks of IVDs.
Therefore, based on the provided information, the Zionic Aesthetic is a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Zionic Aesthetic is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
Product codes
PBX
Device Description
The ZIONIC ASTHETIC is a resistive radiofrequency device which output energy can reach up to 200W. It has two different electrodes with different sizes, to adapt the treatment to the different body areas. The electrodes roll to perform a massage while applying the radiofrequency energy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation activities were successfully completed and establish that the ZIONIC AESTHETIC control unit performs as intended. Testing included the following:
- IEC 60601-1:2005 + Corr.1:2006 + A1:2012; 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.
In addition, tests were performed to demonstrate that the device can maintain a temperature of 40 treatment C for 10 minutes of treatment for every electrode used. Performance testing was performed to demonstrate the accuracy of the output power, output frequency, and output voltage.
Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.
Tests for the Zionic Aesthetic included two patients and three test sites – abdomen, thighs, and arms—and a temperature of 40° C (+2 °C) was maintained for 10 minutes of treatment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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June 8, 2023
TermoSalud % Aubrey Thompson Regulatory Consultant Hoy and Associates Regulatory Consulting 1830 Bonnie Way Sacramento, California 95825
Re: K230659
Trade/Device Name: Zionic Aesthetic Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: March 8, 2023 Received: March 9, 2023
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 (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 located 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
| Mark
Trumbore -S | | | | Digitally signed by
Mark Trumbore -S
Date: 2023.06.08
15:25:02 -04'00' |
| --------------------- | -- | -- | -- | --------------------------------------------------------------------------------- |
|---|
Mark Trumbore, Ph.D. 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
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Indications for Use
510(k) Number (if known) K230659
Device Name Zionic Aesthetic
Indications for Use (Describe)
The Zionic Aesthetic is intended to provide topical heating tor the purpose of elevating tissue temperature for treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The massage device provided 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) |
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510(K) Summary ZIONIC AESTHETIC K230659
This 510(K) Summary of safety and effectiveness for the ZIONIC AESTHETIC is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant | TermoSalud |
|---|---|
| Address | Ataulfo Friera Tarfe, 8 -33211 Gijón, Spain |
| Contact Person | Aubrey Thompson, Regulatory Consultant |
| Contact Information | aubreythompson@hoyregulatory.com |
| (323)533-8994 | |
| Preparation Date | June 8, 2023 |
| Device Trade Name | ZIONIC AESTHETIC |
| Common Name | Massager, vacuum, radio frequency induced heat |
| Regulation Number | 878.4400 |
| Product Code | PBX |
| Regulatory Class | II |
| Legally Marketed Predicate Device | Nuera Tight RF (K200359) |
Device Description:
The ZIONIC ASTHETIC is a resistive radiofrequency device which output energy can reach up to 200W. It has two different electrodes with different sizes, to adapt the treatment to the different body areas. The electrodes roll to perform a massage while applying the radiofrequency energy.
Indications for use:
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.
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510(K) Summary ZIONIC AESTHETIC K230659
Substantial Equivalence—Indications for Use:
| Subject Device – K230659 | Predicate Device -K200359 | Comparison |
|---|---|---|
| The ZIONIC AESTHETIC is intended: | ||
| • 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 local circulation; | ||
| • The massage device is intended to provide a temporary | ||
| reduction in the appearance of cellulite. | The NuEra Tight RF Family is intended: | |
| • 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 local circulation; | ||
| • to provide, with a massage device, a temporary reduction in | ||
| the appearance of cellulite. | Same |
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K230659
| Technical Comparison | ZIONIC AESTHETIC | Nuera Tight RF – K200359 | Comparison |
|---|---|---|---|
| Modes of action | Monopolar radiofrequency | Monopolar and bipolar radiofrequency | Same. The Nuera Tight RF device contains an additional bipolar handpiece that the Zionic does not. |
| Mechanism of action | Electromagnetic waves penetrate in exposed tissue and produce heat, increasing the temperature on a certain part of the body for therapeutic purposes. | Electromagnetic waves penetrate in exposed tissue and produce heat, increasing the temperature on a certain part of the body for therapeutic purposes. | Same |
| Clinical use | Prescription Use | Prescription Use | Same |
| Electrical Protection | Class I type BF | Class I type BF | Same |
| User Interface | Touchscreen | Touchscreen | Same |
| Firmware Controlled | Yes | Yes | Same |
| Type of energy | Radiofrequency waves | Radiofrequency waves | Same |
| Temperature Control | Yes | Yes | Same |
| Frequency | 470kHz | 470 kHz; 1 MHz; 2 MHz; 4 MHz ; 6 MHz | ZIONIC AESTHETIC working frequency is identical to one of the working frequencies of the predicate device Nuera Tight RF. |
| Output RF Power | Max 200 W | Max 250 W | Nearly identical. ZIONIC AESTHETIC maximum power is 20% lower than NueraTight RF, which does not generate safety or performance issues, as an output power of 200W is enough to achieve the desired temperature for the effectiveness of the treatment, and lowering the output power makes the |
| device safer. | |||
| Voltage | 115VAC (with external autotransformer) or 230VAC | 100-240VAC | Same |
| Handpieces | |||
| ZIONIC AESTHETIC | Nuera Tight | ||
| Transfer technology | Monopolar Resistive | Resistive and capacitive monopolar and bipolar | Predicate device includes both transfer modes, monopolar and bipolar, resistive and capacitive. |
| Electrode area | 57/90mm | 20/30/40/60/80/100mm | Very similar- the Nuera Tight device includes more variety of electrode sizes, with lower contact surface that are not included with the Zionic. |
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510(K) Summary ZIONIC AESTHETIC K230659
Performance Testing
Verification and validation activities were successfully completed and establish that the ZIONIC AESTHETIC control unit performs as intended. Testing included the following:
- IEC 60601-1:2005 + Corr.1:2006 + A1:2012; 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.
In addition, tests were performed to demonstrate that the device can maintain a temperature of 40 treatment C for 10 minutes of treatment for every electrode used. Performance testing was performed to demonstrate the accuracy of the output power, output frequency, and output voltage.
Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.
Conclusion
The ZIONIC AESTHETIC and NueraTight RF are identical in their indications for use and nearly identical in their overall design. The key specification to compare for monopolar radiofrequecy transfer technology is the output power, which is slightly lower in the ZIONIC AESTHETIC. This difference in the maximum output power does not generate safety or performance issues, but increases the safety of the device. Both devices underwent thermal testing to show that they can maintain the desired temperature during treatment. Tests for the Zionic Aesthetic included two patients and three test sites – abdomen, thighs, and arms—and a temperature of 40° C (+2 °C) was maintained for 10 minutes of treatment. Test performed on the predicate device showed the same performance. The device maintained a temperature of 40°C (+2°C) for 15 minutes when test sites and 2 patients. It can be concluded, therefore, that performance between the ZIONIC AESTHETIC and the predicate device are substantially equivalent and therefore the two devices are substantially equivalent.