V20 SYSTEM

K142093 · Viora , Ltd. · GEX · Nov 14, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142093
• Device Name: V20 SYSTEM
• Applicant: Viora , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Viora V20 system is intended for dermatological procedures. The V-ST Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The V-IPL Handpiece with wavelengths 415-1200nm (with 5 different filters) is indicated for the treatment of: - Moderate inflammatory acne vulgaris. - Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). - Cutaneous lesions including warts, scars and striae. - Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte and venous malformations. - Removal unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Device Story

V20 system is a multi-application platform for dermatological procedures; utilizes two handpieces: V-ST (bipolar radiofrequency) and V-IPL (intense pulsed light, 415-1200nm). Main console provides operational/safety functions; operator adjusts treatment parameters based on patient skin condition/anatomy; foot switch used for activation. Device used in clinical settings by trained operators. Output consists of RF energy or pulsed light delivered to target tissue to achieve therapeutic effects (e.g., hair reduction, vascular/pigmented lesion treatment, muscle pain relief). Benefits include non-invasive management of various dermatological conditions and cosmetic improvements.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-57 standards demonstrated safety and effectiveness.

Technological Characteristics

Multi-application platform; V-ST handpiece (bipolar RF); V-IPL handpiece (415-1200nm, 5 filters). Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-2 (HF surgical), and IEC 60601-2-57 (non-laser light). Console-based system with foot switch activation.

Indications for Use

Indicated for patients requiring dermatological procedures, including relief of minor muscle aches, pain, and spasms; improvement of local blood circulation; treatment of moderate inflammatory acne vulgaris, benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, freckles), cutaneous lesions (warts, scars, striae), benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, poikiloderma of Civatte, venous malformations), and hair removal/permanent hair reduction.

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

• Viora V-total™ (K133837)

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

November 14, 2014

Viora LTD. Mr. Omri Kesler Chief Operating Officer 3 Maskit Street 46733 Herzliya Israel

Re: K142093

Trade/Device Name: V20 System Regulation Number: 21 CFR 878.4810, 21 CFR 878.4400 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology, Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEX, PBX Dated: October 12, 2014 Received: October 16, 2014

Dear Mr. Kesler:

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

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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 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

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K142093

Device Name V20 system

Indications for Use (Describe)

The Viora V20 system is intended for dermatological procedures.

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

The V-IPL Handpiece with wavelengths 415-1200nm (with 5 different filters) is indicated for the treatment of:

- · Moderate inflammatory acne vulgaris.
- · Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
- · Cutaneous lesions including warts, scars and striae.
- · Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte and venous malformations.
- · Removal unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

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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Image /page/3/Picture/0 description: The image shows the logo for VIORA. The logo consists of a stylized infinity symbol above the word "VIORA" in a bold, sans-serif font. Below the word "VIORA" is the tagline "Shape the Future" in a smaller, lighter font.

## 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21

CFR 807.92.

| Submitter Name<br>and Address: | Viora Ltd.<br>3 Maskit Street<br>Herzliya, Israel 46733<br>Israel |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Omri Kesler<br>COO<br>Email: [e-mail]<br>Phone Number: [phone]<br>Fax Number: [phone] |
| Establishment<br>Registration<br>Number: | 3005695724 |
| Date Prepared: | July 29, 2014 |
| Device Trade<br>Name(s): | V20 system |
| Device Common<br>Name: | Multi application RF and IPL device |
| Classification: | Name: Laser surgical instrument for use in general and plastic<br>surgery and in dermatology and Electrosurgical cutting and<br>coagulation device and accessories.<br>Product code: GEX, PBX<br>Regulation No: 21 CFR878.4810, 21CFR878.4400<br>Class: II<br>Panel: General and plastic surgery devices |
| Predicate<br>Device(s): | Viora V-total™ (K133837) |

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Image /page/4/Picture/0 description: The image shows the logo for VIORA. The logo consists of a stylized graphic above the word "VIORA" in a bold, sans-serif font. Below the word "VIORA" is the tagline "Shape the Future" in a smaller, lighter font. The graphic above the wordmark appears to be an abstract design, possibly representing an infinity symbol or a stylized leaf.

#### Device description

The Viora V20 system is a RF and IPL multi application platform with two available treatment Handpieces:

V-ST Handpiece: Bi polar radiofrequency (RF) Handpieces

V-IPL Handpiece: Intense Pulsed Light (IPL) Handpiece

The Main Unit (console) provides the operational and safety function of the system.

The operator can modify the treatment parameters to achieve specific tissue effects

depending on individual patient's skin condition and anatomical structure. The Foot Switch is used for system activation.

### Intended use and indication for use statement

The Viora V20 system is intended for dermatological procedures.

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

The V-IPL Handpiece with wavelengths 415-1200nm (with 5 different filters) is indicated for the treatment of:

- Moderate inflammatory acne vulgaris.
- . Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
- . Cutaneous lesions including warts, scars and striae.
- . Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte and venous malformations.
- . Removal unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

### Predicade Devices

Substantial equivalence to the following predicate device is claimed:

| Device Name | 510k No. | Date of Clearance |
|----------------|----------|-------------------|
| Viora V-total™ | K133837 | April 9, 2014 |

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Image /page/5/Picture/0 description: The image shows the logo for VIORA. The logo consists of a stylized infinity symbol above the word "VIORA" in a bold, sans-serif font. Below the word "VIORA" is the tagline "Shape the Future" in a smaller, lighter font. The logo is black and white.

#### Substantial Equivalence to Predicate Device

The V20 system and its predicate have the same intended use and the same indications for use (for the ST and IPL Handpieces). Furthermore, the V20 system and the predicate device have similar technological features. The Viora V20 V-ST and V-IPL Handpieces are exactly the same as the cleared Viora V-total ST and IPL Handpieces (k133837).

Any differences in the software and in the system design do not raise any new issues of safety and effectiveness, as was verified by performance testing. Therefore, the V20 system is substantially equivalent to its predicate device.

#### Performance standards

The V20 system complies with:

- . IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
- . IEC 60601-1-2: 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: 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 60601-2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use.

#### Performance Bench Tests

Bench testing demonstrated that the V20 system is as safe and effective as the cleared predicate devices.

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Image /page/6/Picture/0 description: The image shows the logo for VIORA. The logo consists of a stylized infinity symbol above the word "VIORA" in a bold, sans-serif font. Below the word "VIORA" is the tagline "Shape the Future" in a smaller, lighter font. The logo is black and white.

## Pre-Clinical and clinical study

Since the technological parameters of the Viora V20 system are well within the previously cleared Viora V-total system, Viora believes that animal and clinical studies are not required to determine the safety and efficacy of the V20 system.

#### Conclusion

Based on the technological characteristics of the devices and the intended use, Viora believes that the V20 system and the predicate device are substantially equivalent. The differences do not raise any new issues of safety or effectiveness.