Symmed Elite Aesthetic

K230412 · Termosalud · PBX · Apr 13, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230412
• Device Name: Symmed Elite Aesthetic
• Applicant: Termosalud
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Apr 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Radiofrequency (RF) generator; delivers monopolar RF current to patient tissues via resistive and capacitive electrodes; includes optional massage function. Used in clinical settings by professionals. Console generates 448 kHz RF current; energy delivered through handpieces connected by cables; reusable neutral return electrode required. Device elevates tissue temperature to treat pain, muscle spasms, and improve local circulation; massage function targets cellulite appearance. Healthcare provider monitors treatment via console display; output parameters (frequency, power, impedance) controlled to maintain therapeutic tissue heating. Benefits include non-invasive pain relief and temporary aesthetic improvement.

Clinical Evidence

No clinical investigations were conducted. Evidence consists of bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), high-frequency surgical equipment safety (IEC 60601-2-2), and biocompatibility (ISO 10993-1). In-house validation demonstrated the device maintains a skin surface temperature of 40°C for 10 minutes using various electrode sizes.

Technological Characteristics

Radiofrequency generator; 448 kHz output; 200W max power; monopolar modality. Includes capacitive and resistive electrodes (30, 50, 70mm diameters) and reusable neutral return electrode. 10.2" color touchscreen display. Operates at 115/230V AC. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and ISO 10993-1 standards.

Indications for Use

Indicated for patients requiring topical heating for relief of pain, muscle spasms, or increased local circulation, and for temporary reduction in the appearance of cellulite.

Regulatory Classification

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.

Predicate Devices

• Indiba Diathermia RF (K161458)

Submission Summary (Full Text)

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April 13, 2023

TermoSalud % Ms. Aubrey Thompson, MS Regulatory Consultant Hoy and Associates Regulatory Consulting 1830 Bonnie Way Sacramento, California 95825

Re: K230412

Trade/Device Name: Symmed Elite Aesthetic Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: February 14, 2023 Received: February 15, 2023

Dear Ms. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.04.13
10:47:10 -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) K230412

Device Name Symmed Elite Aesthetic

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(K) Summary Symmed Elite Aesthetic K230412

This 510(K) Summary of safety and effectiveness for the Symmed Elite 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 | Ms. Aubrey Thompson, MS<br>Regulatory Consultant |
| Contact Information | [e-mail]<br>[phone] |
| Preparation Date | 1830 Bonnie Way<br>Sacramento, CA 95825<br>April 12, 2023 |
| Device Trade Name | Symmed Elite Aesthetic |
| 510(k) Number<br>Common Name | K230412<br>Radiofrequency Device |
| Regulation Number | 21 CFR 878.48400 |
| Product Code | PBX |
| Regulatory Class | 2 |
| Legally Marketed Predicate<br>Device | Indiba Diathermia RF (K161458) |

### Device Description:

The Symmed Elite Aesthetic device is a radiofrequency generator that is used for a number of pain related applications such as" to relieve pain, muscle spasms and increase local circulation through electrical and thermal stimulation of the treated tissues". In addition, it contains a massage function that provides temporary improvement in the appearance of cellulite. The Symmed Elite Aesthetic consists of a console plus 2 handpieces, each with 3 different size electrodes. Each handpiece is capable of being fitted with the optional massager. This allows for flexible treatment parameters throughout the working range and handpieces.

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# 510(K) Summary Symmed Elite Aesthetic K230412

### Indications for use:

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.

| Specification | Symmed | Indiba Diathermia RF | Comparison |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indications for Use | The Symmed Elite<br>Aesthetic is intended to<br>provide topical heating<br>for the purpose of<br>elevating tissue<br>temperature for<br>treatment of selected<br>medical conditions<br>such as: relief of pain,<br>muscle spasms,<br>increase in local<br>circulation. The<br>massage device<br>provided is intended to<br>provide a temporary<br>reduction in the<br>appearance of cellulite. | The Indiba Diathermia<br>Radiofrequency<br>Devices are intended to<br>provide topical heating<br>for the purpose of<br>elevating tissue<br>temperature for<br>treatment of selected<br>medical conditions<br>such as: relief of pain,<br>muscle spasms,<br>increase in local<br>circulation. The<br>massage device<br>provided is intended to<br>provide a temporary<br>reduction in the<br>appearance of cellulite. | Same |
| General Description | The Symmed Elite<br>Aesthetic<br>Radiofrequency Device<br>is a therapeutic device<br>used for pain-related<br>applications. The<br>device consists of a<br>console which<br>generates a<br>radiofrequency current<br>which is delivered to<br>the patient, in<br>monopolar form,<br>through two different<br>types of electrodes:<br>resistive and | The Indiba Diathermia<br>Radiofrequency Device<br>is a therapeutic device<br>for deep,<br>non-invasive<br>diathermy. The device<br>consists of a console<br>which generates a<br>radiofrequency current<br>which is delivered to<br>the patient, in<br>monopolar form,<br>through two different<br>types of electrodes:<br>resistive and<br>capacitive. The | Same |
| K230412 | | | |
| | inserted into a<br>handle/handpiece, one<br>handle for each kind of<br>electrode, and the<br>handle is connected to<br>the console by means<br>of a cable. | handle/handpiece, one<br>handle for each kind of<br>electrode, and the<br>handle is connected to<br>the console by means<br>of a cable. | |
| Modality | Monopolar | Monopolar | Same |
| Output Frequency | 448 kHz +/- 10% | 448 kHz | Same |
| Input Voltage Supply | 230 V a.c 50/60 Hz<br>115 V a.c 50/60 Hz* | (100 - 130) V~ 50/60 Hz | Same when auto-<br>transformer is used |
| Maximum power | 200 W | 200W | Same |
| Operating Temperature | +10°C to +40°C | +10°C to +40°C | Same |
| Timer Range | 60 minutes | 0 - 99 minutes | Different |
| Electrodes | Capacitive and<br>Resistive | Capacitive and<br>Resistive | Same |
| Return | Reusable Neutral<br>Return Electrode | Reusable Neutral<br>Return Electrode | Same |
| Temperature Range for<br>operation | +17 °C - 30°C | +10°C to +40°C | Within the range of the<br>predicate's |
| Temperature range for<br>storage and transport | No Restrictions | -20°C to +50°C | Different, but does not<br>impact safety or<br>efficacy |
| Display | 10,2" Color Display<br>Touch Screen with LED<br>Backlight | 5.7 inch TFT color 320 x<br>240 pixels | Different, but does not<br>impact safety or<br>efficacy |

#### Substantial Equivalence—Technological Characteristics:

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# 510(K) Summary Symmed Elite Aesthetic

### Performance Testing

Verification and validation activities were successfully completed and establish that the Symmed Elite Aesthetic performs as intended. Testing included the following:

IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility 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

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## 510(K) Summary Symmed Elite Aesthetic K230412

ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Software verification and validation testing was conducted to IEC 62304:2006/A1:2016, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

Performance testing was conducted to show that frequency, impedance, voltage output, and output power all performed within the accepted range.

The Symmed Elite Aesthetic device has been validated through an in-house study to demonstrate that the device can maintain a skin surface temperature of 40°C for 10 minutes of treatment. The 3 resistive electrodes (diameters 30, 50 and 70mm), and the 3 capacitive electrodes (diameters 30, 50 and 70mm), were utilized for the evaluation of the tissue heating in both treatment modalities (capacitive and resistive respectively).

### Clinical Evidence

No clinical investigations were conducted as part of this submission.

#### Conclusion

The indications for use, functionality, type and design of electrodes, skin temperature sensing of the Symmed Elite Aesthetic are similar to the same of the legally marketed predicate device. Performance testing conducted on the Symmed Elite Aesthetic demonstrated performance substantially equivalent to the predicate. Therefore, Symmed Elite Aesthetic device is as safe, as effective, and performs as well as or better than the legally marketed predicate device for requested interdictions for use.