T-SHAPE 2

K231092 · B&M S.R.L. Marketing Nel Benessere · NUV · Sep 22, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K231092
• Device Name: T-SHAPE 2
• Applicant: B&M S.R.L. Marketing Nel Benessere
• Product Code: NUV · General, Plastic Surgery
• Decision Date: Sep 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The T-SHAPE 2 and its hand pieces are indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

Device Story

T-SHAPE 2 is a multifunction platform for aesthetic and therapeutic tissue treatment. It uses simultaneous application of infrared light (650/980 nm), bipolar radio frequency (RF) energy (500 kHz–2 MHz), vacuum suction, and mechanical massage via motorized rollers or spheres. The device comprises a main console and various handpieces (multipole, thermal imaging, roller, and sphere-based). Operators select treatment parameters—intensity, frequency, suction, and duration—via a graphic user interface. A microprocessor controller monitors system functions and safety parameters, including skin resistance and endogenous heat levels, to prevent excessive heating. The device is intended for use in clinical settings by trained operators. It benefits patients by providing non-invasive tissue manipulation and heating to address muscle-related discomfort and cosmetic concerns.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing per ISO 10993, electrical safety and EMC testing per IEC 60601-1/60825-1/60601-1-2, and software verification/validation. Performance bench testing included instrumental analysis and consumer self-assessments under medical supervision to verify skin tolerance and cosmetic effects.

Technological Characteristics

Multifunction platform with infrared light (650/980 nm), bipolar RF (500 kHz, 1 MHz, 1.5 MHz, 2 MHz), vacuum (up to -400 mbar), and mechanical massage. Components include a main console and multiple handpieces (multipole, roller, sphere). Materials are biocompatible per ISO 10993. Safety features include real-time monitoring of skin resistance (50-500 Ohm) and endogenous heat. Software-controlled via microprocessor. Sterilization not specified; device is for professional use.

Indications for Use

Indicated for relief of minor muscle aches/pains, muscle spasms, temporary improvement of local blood circulation, and temporary reduction in cellulite appearance in adult patients.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• VelaShape (K122579)
• Venus Legacy Pro (K191528)
• ICOONE Laser Med (K211272)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 22, 2023

B&M S.R.L. Marketing Nel Benessere % Chiara Violini Consultant Endo Engineering Srl Via Del Consorzio, 41 Falconara Marittima, Ancona 60015 Italy

Re: K231092

Trade/Device Name: T-shape 2 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: NUV, PBX Dated: August 22, 2023 Received: August 23, 2023

Dear Chiara Violini:

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

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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 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 [phone] or 301-796-7100).

Sincerely.

Tanisha L. Hithe -S Tanisha L. 2023.09.22 Hithe -S 20:49:01 -04'00'

Tanisha Hithe, MS, MHS 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K231092

Device Name T-SHAPE 2

Indications for Use (Describe)

The T-SHAPE 2 and its hand pieces are indicated for the relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation and 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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Image /page/3/Picture/0 description: The image shows the text "BALDAN" in large, bold, sans-serif font, with a horizontal line directly underneath it. Below the line, the word "GROUP" is printed in a smaller, sans-serif font, with each letter aligned directly under the corresponding letter of "BALDAN". The text is black against a white background.

# 510(k) Summary

K231092

### Introduction:

This document contains the 510(k) Summary for the T-SHAPE 2 device. The content of this summary is based on the requirements of 21 CFR 807.92(c).

| Applicant/ | B&M S.R.L. |
|------------------------------|------------------------------------------------------------|
| Manufacturer | MARKETING NEL BENESSERE |
| Name and Address: | Via Leonardo Bruni, 25 |
| | 20158 Milano (MI) |
| | Italy |
| 510(k) Contact Person: | Chiara Violini |
| | Consultant |
| | Email: [e-mail] |
| | Phone: [phone] |
| | Fax: [phone] |
| Date Prepared: | 30/01/2023 |
| Device Name: | T-SHAPE 2 |
| Common or Usual Name: | Multifunction platform with LLLT, RF, vacuum and massager. |
| Classification: | Class II |
| Classification Name: | Massager, Vacuum, Light Induced Heating (NUV) |
| | Massager, Vacuum, Radio Frequency Induced Heat (PBX) |
| Regulation number: | 21 CFR 878.4810 (NUV) |
| | 21 CFR 878.4400 (PBX) |
| Classification product code: | NUV, PBX |
| Predicate Devices: | K122579 – VelaShape – Syneron Medical, Limited |
| | K191528 – Venus Legacy Pro – Venus Concept Ltd. |
| | K211272 – ICOONE Laser Med – I-Tech Industries SRL |

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Image /page/4/Picture/0 description: The image shows the text "BALDAN" in a bold, sans-serif font, with a horizontal line underneath. Below the line, the word "GROUP" is printed in a smaller, sans-serif font, with each letter centered under the corresponding letter of "BALDAN". The overall design is simple and clean, likely representing a company or organization name.

### Description of the device:

T-SHAPE 2 treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.

The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an targeted manner.

T-SHAPE 2 is also equipped with:

- Two light sources type inside some handpieces (see below) with the following wavelengths: 650 and l 980 nm.
- -Electrodes for bipolar RF energy (500 kHz/ 1 MHz / 1,5 MHz).

Through the display, the light sources and RF energy can be fully deactivated or activated.

The light sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).

For the RF energy the user can select frequency between 2 MHz, 1 MHz, 500 kHz and intensity between the 10 levels available.

T-SHAPE 2 comprises a main console unit and several handpieces.

A microprocessor-based system controller is used to monitor and direct all the system function and the graphic user interface.

The main console can be connected to the following handpieces (two different hand piece can be connected at the same time):

- -Large multipole handpiece with 6 diode laser and 6 RF plates;
- -Medium multipole handpiece with 4 diode laser and 4 RF plates;
- -Small multipole handpiece 4 RF plates and 1 red LED;
- -Thermal imaging camera;
- -Roll handpiece with 4 diode laser and 2 motorized roller with RF;
- -Mesosphere handpiece with 45 motorized rotating spheres.

### Indication for Use:

The T-SHAPE 2 and its hand pieces are indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

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Image /page/5/Picture/0 description: The image shows the logo for Baldan Group. The word "BALDAN" is in large, bold, sans-serif font, with a horizontal line underneath. Below the line, the word "GROUP" is written in a smaller, sans-serif font, with each letter centered under the corresponding letter of "BALDAN".

### Comparison of Technological Characteristics:

T-SHAPE 2 has the same technological characteristics (massager, vacuum, RF energy, light source, control mechanisms) and specifications as its predicate devices.

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| BALDAN<br>GROUP | T-SHAPE 2 | B&M S.R.L.<br>MARKETING NEL BENESSE<br>Via Leonardo Bruni, 25 |
|-----------------|-----------|---------------------------------------------------------------|
| | | 20158 Milano (MI)<br>Phone: [phone] |
| | | Email: info@baldangroup. |

| Specifications | Predicate Device<br>(Primary) | Predicate Device | Predicate Device | Device object of 510(k) | Comparison to<br>Predicate |
|---------------------------|-------------------------------|---------------------------------------------------------------------------------------|--------------------------------|------------------------------------------|-------------------------------------------------------------------------------------------|
| Device Name<br>(K number) | VelaShape<br>K122579 | Venus Legacy Pro<br>K191528 with 4D<br>Body (LB2) and 4D<br>Face (LF2)<br>applicators | ICOONE Laser Med<br>K211272 | T-SHAPE 2 | / |
| Submitter | Syneron Medical,<br>Limited | Venus Concept Ltd. | I-Tech Industries SRL | B&M S.R.L.<br>MARKETING NEL<br>BENESSERE | / |
| Product Code | NUV | GEX, PBX | NUV, ISA | NUV, PBX | Not considered ISA<br>and GEX because<br>they are already<br>considered in NUV<br>and PBX |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4400 | 21 CFR 878.4810 | 21 CFR 878.4810 | / |
| Regulatory Class | II | II | II | II | / |
| Product Picture | Image: Velashape device | Image: Venus Legacy Pro device | Image: ICOONE Laser Med device | Image: T-Shape 2 device | / |

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| B | A | L | D | N |
|---|---|---|---|---|
| G | R | O | U | P |

# T-SHAPE 2

Via Leonardo Bruni, 25 20158 Milano (MI) Phone: [phone]
Email: [e-mail]

| Specifications | Predicate Device<br>(Primary) | Predicate Device | Predicate Device | Device object of 510(k) | Comparison to<br>Predicate |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Device Name<br>(K number) | VelaShape<br>K122579 | Venus Legacy Pro<br>K191528 with 4D<br>Body (LB2) and 4D<br>Face (LF2)<br>applicators | ICOONE Laser Med<br>K211272 | T-SHAPE 2 | / |
| Mains | 110 VAC; 4A; 50 Hz;<br>Single Phase<br>230 VAC; 2.5A; 50 Hz;<br>Single Phase | 100-120 VAC / 60Hz<br>220-240 VAC / 50Hz | 240/110 Vac | 100-120 VAC / 60Hz<br>220-240 VAC / 50Hz | Equivalent to<br>Predicate Devices |
| Weight | 20 kg. / 44.1 lbs | 40 kg | 191,80 lb (87 kg) | 95 kg | Equivalent to<br>Predicate Devices |
| Dimensions | 38 x 49 x 132 cm /<br>15 x 19 x 51.8 inch | 40X40X100 cm<br>(DxWxH) | 37,40x80,71x19,68<br>inch (95x205x50 cm) | 57 x 86 x 1.70 cm | Equivalent to<br>Predicate Devices |
| Biocompatibility | Unknown | Materials are<br>biocompatible | Biological Evaluation<br>Of Medical Devices -<br>Part 10: Tests For<br>Irritation And Skin<br>Sensitization /<br>Biological Evaluation<br>Of Medical Device -<br>Part 5: Test for<br>cytotoxicity - According<br>to ISO10993-10:2010,<br>10993-5:2009 and<br>10993-12:2012 | Biological evaluation<br>for cytotoxicity,<br>irritation, and skin<br>Sensitization | Equivalent to<br>Predicate Devices |
| Specifications | Predicate Device | Predicate Device | Predicate Device | Device object of 510(k) | Comparison to |
| | (Primary) | | | | Predicate |
| Device Name<br>(K number) | VelaShape<br>K122579 | Venus Legacy Pro<br>K191528 with 4D<br>Body (LB2) and 4D<br>Face (LF2)<br>applicators | ICOONE Laser Med<br>K211272 | T-SHAPE 2 | / |
| Indications for use | The VelaShape is<br>indicated for the relief<br>of minor muscle aches<br>and pain, relief of<br>muscle spasm,<br>temporary<br>improvement of local<br>blood circulation,<br>temporary reduction in<br>the appearance of<br>cellulite, and for<br>temporary reduction<br>of thighs<br>circumferences. | When used with the<br>4D Body (LB2) and 4D<br>Face (LF2) applicators,<br>the Venus Legacy Pro<br>device is intended for<br>the delivery of non-<br>thermal RF combined<br>with Massage and<br>magnetic field pulses<br>for the treatment of<br>the following medical<br>conditions:<br>• Relief of minor<br>muscles aches and<br>pain, relief of muscle<br>spasm<br>• Temporary<br>improvement of local<br>blood circulation<br>• Temporary reduction<br>in the appearance of<br>cellulite | ICOONE Laser med<br>(also referred to as<br>ICOONE Medical laser)<br>is indicated for the<br>relief of minor muscle<br>aches and pain, relief<br>of muscle spasms,<br>temporary<br>improvement of local<br>blood circulation, and<br>temporary reduction in<br>the appearance of<br>cellulite. | The T-SHAPE 2 and its<br>hand pieces are<br>indicated for the relief<br>of minor muscle aches<br>and pain, relief of<br>muscle spasms,<br>temporary<br>improvement of local<br>blood circulation, and<br>temporary reduction in<br>the appearance of<br>cellulite. | Equivalent to<br>Predicate Devices |
| System component | Light, RF, Massage,<br>Suction, Rollers | RF, Massage, Suction,<br>Rollers | Light, Massage,<br>Suction, Rollers | Light, RF, Massage,<br>Suction, Rollers | Equivalent to<br>primary predicate<br>device |
| Massage | | | | | |

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B A L D A N
GROUP

# T-SHAPE 2

Via Leonardo Bruni, 25 20158 Milano (MI) Phone: [phone]
Email: [e-mail]

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| BALDAN<br>GROUP | T-SHAPE 2 | B&M S.R.L.<br>MARKETING NEL BENESSERE<br>Via Leonardo Bruni, 25<br>20158 Milano (MI)<br>Phone: [phone]<br>Email: [e-mail] |
|-----------------|-----------|------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------|-----------|------------------------------------------------------------------------------------------------------------------------------------------------|

| Specifications | Predicate Device<br>(Primary) | Predicate Device | Predicate Device | Device object of 510(k) | Comparison to<br>Predicate |
|-----------------------------------|-------------------------------|---------------------------------------------------------------------------------------|--------------------------------|------------------------------------------------------------|----------------------------------------------|
| Device Name<br>(K number) | VelaShape<br>K122579 | Venus Legacy Pro<br>K191528 with 4D<br>Body (LB2) and 4D<br>Face (LF2)<br>applicators | ICOONE Laser Med<br>K211272 | T-SHAPE 2 | / |
| Mechanical<br>Massage | Yes | Yes | Yes | Yes | Equivalent to<br>Predicate Devices |
| Light | | | | | |
| Infrared<br>wavelengths | 850 nm | Not present | 650nm (LED)/ 915 nm<br>(LASER) | 650/980 nm | See Substantial<br>Equivalence<br>discussion |
| Maximum<br>power/power<br>density | 3.3 W | / | 1 W (915 nm)<br>2.69 W/m² | 2 W/m² | / |
| Suction/vacuum | | | | | |
| Mode | Pulsed | Unknown | Fractioned | Pulsed | Equivalent to<br>predicate devices |
| Maximum Pressure | - 390 mbar | - 400 mbar | Unknown | - 400 mbar | Equivalent to<br>predicate devices |
| Radio Frequency | | | | | |
| Frequency | 1 MHz | 1 MHz | Not present | Selectable between<br>2 MHz<br>1,5 MHz<br>1 MHz<br>500 kHz | See Substantial<br>Equivalence<br>discussion |
| Peak RF POWER | 150 W | 150 W | / | 150 W | Equivalent to<br>predicate devices |
| Mode | Bi-polar | Bi-polar | / | Bi-polar | Equivalent to<br>predicate devices |

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Image /page/10/Picture/0 description: The image shows the logo for Baldan Group. The word "BALDAN" is written in large, bold, serif font, with a horizontal line running underneath it. Below the line, the word "GROUP" is written in a smaller, sans-serif font. The letters are evenly spaced and the overall design is simple and professional.

### Performance data:

The following performance data are provided in support of the substantial equivalence determination:

### Biocompatibility testing

Materials in contact with patient skin, for a duration less than 24 hours, were evaluated according to the "biocompatibility flow chart for the selection of toxicity tests for 510(k)s", attachment C of "Criteria of Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (blue book memo)".

### Safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the T-SHAPE 2 device.

The system complies with the IEC 60601-1, IEC 60825-1 standards for safety and the IEC 60601-1-2 and IEC TR 60601-4-2 standards for EMC.

### Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

### Performance Bench Testing

T-SHAPE 2 has been evaluated to verify the skin tolerance, effect and cosmetic properties of a professional treatment through evaluations and instrumental analysis performed by professionals under medical supervision and consumer self-assessments.

### Comparison of Intended Use:

T-SHAPE 2 device's Intended Use is the same Intended Use of its predicate device.

### Substantial Equivalence:

T-SHAPE 2 device is as safe and effective as its predicate devices.

T-SHAPE 2 device has the same intended use and same technological characteristics and specification as its predicate devices, moreover, T-SHAPE 2 has been tested in accordance to consensus standard to demonstrate safety and Performance.

The choice of four frequencies allows you to act more precisely on different layers of the tissue, contrary to a single fixed frequency.

The safety of the treatment is due to the characteristics of the latest generation equipment, which allow you to constantly monitor the parameters set during the session. The system has two safety levels: the first is preset on the skin resistance values with gradual emission of current pulses, the skin resistance have been considered variable between 50 and 500 Ohm and the voltage and power values of the settable 10 level has been calculated considering this range of skin resistance; the second is the intensity by the operator who monitors moment by moment the progress of the treatment and the endogenous heat triggered. Each frequency level respects this operating mode to avoid excessive heating.

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Image /page/11/Picture/0 description: The image shows the text "BALDAN" in large, bold letters, with a horizontal line running underneath it. Below the line, the word "GROUP" is written in smaller letters, aligned with the letters above. The text appears to be a logo or heading, possibly for a company or organization named Baldan Group.

Thus, T-SHAPE 2 device is substantially equivalent to its predicate devices.

### Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, than the legally marketed predicate devices.