VIORA V-TOUCH

K141904 · Viora , Ltd. · GEI · Oct 21, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141904
• Device Name: VIORA V-TOUCH
• Applicant: Viora , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Viora V-Touch is intended for dermatological procedures. The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.

Device Story

V-Touch is a multi-application RF device combining CORE (Channeling Optimized RF Energy) technology with mechanical vacuum massage. The system utilizes the ST applicator, which delivers bipolar RF energy via two electrodes. The device is intended for use in clinical settings by healthcare professionals. By applying RF energy and vacuum, the device aims to provide therapeutic relief for muscle-related conditions and improve local blood circulation. The healthcare provider operates the applicator directly on the patient's skin; the output is intended to alleviate pain and muscle spasms, providing symptomatic relief.

Clinical Evidence

Bench testing only. Validation and verification testing were performed, including RF power accuracy testing. No clinical data was required as the device utilizes the same handpiece and technology as the predicate.

Technological Characteristics

Multi-application RF device using CORE (Channeling Optimized RF Energy) and mechanical vacuum. Employs bipolar RF energy via two electrodes in the ST applicator. Complies with IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (High-frequency surgical equipment).

Indications for Use

Indicated for patients requiring dermatological procedures, relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

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

• Viora Reaction (K090221)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 21, 2014

Viora Ltd. % Yoram Levy Qsite 31 Haavoda Street Binyamina. Israel 30500

Re: K141904

Trade/Device Name: V-Touch Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 1, 2014 Received: October 3, 2014

Dear Mr. Levy:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# Indications for Use

510(k) Number (if known) K141904

Device Name V-Touch

| Indications for Use (Describe) | The V-Touch is intended for dermatological procedures. |
|--------------------------------|--------------------------------------------------------|
|--------------------------------|--------------------------------------------------------|

temporary improvement of local blood circulation.

The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY

# V-Touch

# 510(k) Number K141904

| Applicant's Name: | Viora Ltd.<br>3 Maskit Street<br>Herzliya, Israel 46733<br>Tel: [phone]<br>Fax: [phone] |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite<br>31 Haavoda Street<br>Binyamina, Israel 30500<br>Tel +(972)4-638-8837; Fax [phone]<br>[e-mail] |

- Trade Name: V-Touch
- Common Name: Multi application RF Device
- Preparation Date: July 08, 2014
- Classification: Name: Electrosurgical, cutting & coagulation device & accessories Product Code: GEI Regulation No: 21 CFR 878.4400 Class: II Panel: General and Plastic Surgery

# Device Description:

Viora's V-Touch system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The V-Touch system provides the treatments using the following speciallydesigned applicator:

The ST applicator, which was cleared for Viora's Reaction system under K090221, utilizes RF bipolar energy, through 2 electrodes. It is used for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.

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## Intended Use Statement:

The Viora V-Touch is intended for dermatological procedures.

The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.

## Predicate Devices:

Substantial equivalence to the following predicate devices is claimed:

| Device Name | 510k No | Date of Clearance |
|----------------|---------|-------------------|
| Viora Reaction | K090221 | July 1, 2009 |

## Substantial Equivalence to Predicate Devices

The Viora V-Touch includes the ST applicator that is the same applicator that was cleared with the Viora Reaction (K090221).

## Performance Standards:

V-Touch complies with

- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety. Collateral Standard: Safety Requirements
for Medical Electrical Systems.

IEC 60601-1-2 Medical Electrical Equipment Part 1-2: ● Collateral Electromagnetic Compatibility - -Standard: Requirements and Tests.

IEC 60601-2-2 - Medical Electrical Equipment-Part 2: ● Particular requirements for the safety of high frequency surgical equipment.

# Performance Bench Tests and Conclusions

The V-Touch successfully passed validation and verification testing, including testing for RF power accuracy. Predicate comparison of the handpiece was unnecessary, since the predicate device uses the same handpiece. Bench testing demonstrated that the V-Touch is as safe and effective as the cleared predicate device.