VIORA V-TOTAL

K133837 · Viora , Ltd. · GEX · Apr 9, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133837
• Device Name: VIORA V-TOTAL
• Applicant: Viora , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Viora V-total™ is intended for dermatological procedures. The ST handpiece is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation. The 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. The Nd:YAG Laser handpiece with wavelength 1064 nm comes with 4 different applicator spot diameters: 2x4, 3.5; 5.5 and 9.5 mm. The three smaller spot sizes (2x4, 3.5, 5.5 mm) are intended for: Benign vascular lesions such as, but not limited to treatment of: port wine stains, hemangiomas, Warts, superficial and deep telangiectasias (venulectasias), reticular veins (0.1-4.0 mm dia.) of the leg, rosacea, venus lake, leg veins, spider veins, poikiloderma of civatte and angiomas. Benign cutaneous lesions, such as, but not limited to: warts, scars, striae and psoriasis. Benign pigmented lesions such as, but not limited to: lentigos (age spots), solar lentigos (sun spots), cafe-au-lait macules, seborrheic keratosis, nevi and nevus of Ota, chloasma, verrucae, skin tags and keratosis. Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The non-ablative treatment of facial wrinkles, such as, but not limited to: periocular wrinkles and perioral wrinkles. The handpiece with a spot size of 9.5 mm is also is intended for removal of 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 and treatment of pseudofolliculitis barbae (PFB).

Device Story

Viora V-total is a multi-application platform utilizing three distinct handpieces: ST Bi-polar RF, IPL (415-1200nm), and Nd:YAG laser (1064nm). System delivers energy to skin/tissue to treat vascular/pigmented lesions, acne, wrinkles, and unwanted hair, or to provide muscle pain relief. Operated by clinicians in professional settings. Device transforms electrical energy into RF, light, or laser output based on selected handpiece and parameters. Healthcare providers use output to perform dermatological procedures; clinical decision-making relies on provider assessment of lesion type and patient skin condition. Benefits include non-invasive treatment of various cutaneous conditions and permanent hair reduction.

Clinical Evidence

No clinical data provided. Safety and efficacy established via bench testing and reliance on clinical/animal studies previously performed for predicate devices (Viora Reaction, Alma Harmony XL, Omnimax) and published scientific literature.

Technological Characteristics

Multi-technology platform; ST Bi-polar RF, IPL (415-1200nm), and Nd:YAG laser (1064nm). Complies with IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-22, 60601-2-57, and IEC 60825-1. Nd:YAG handpiece features multiple spot sizes (2x4, 3.5, 5.5, 9.5 mm).

Indications for Use

Indicated for patients requiring dermatological procedures, including relief of minor muscle aches/spasms, acne vulgaris, benign pigmented/vascular lesions, unwanted hair removal/reduction, scar/striae treatment, and non-ablative wrinkle reduction. Contraindications not explicitly listed.

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 Reaction System (K090221)
• Alma Harmony XL (K113810)
• OmniMax (K111303)

Submission Summary (Full Text)

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# 510(K) SUMMARY

# V-total™M

## 510(k) Number K133837

| 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 [phone]; Fax [phone]<br>[e-mail] |
| Trade Name: | <i>V-total</i> TM |
| Summary<br>Preparation Date: | December 12, 2013 |
| Classification: | Name: Electrosurgical, cutting & coagulation device & accessories |
| | Product Code: GEX, PBX |
| | Regulation No: 21 CFR 878.4400, 878.4810 |
| | Class: II |
| | Panel: General and Plastic Surgery |

#### Device Description:

The Viora V-total™ system is a multi application, multi-technology platform with four available treatment handpieces (applicators):

- . ST Bi-polar radiofrequency (RF) handpiece
- Intense pulsed light (IPL) handpiece .
- Long pulse neodymium-doped yttrium aluminum (Nd:YAG) laser handpiece .

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The Viora V-total™ is intended for dermatological procedures.

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

The 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.

The Nd:YAG Laser handpiece with wavelength 1064 nm comes with 4 different applicator spot diameters: 2x4, 3.5; 5.5 and 9.5 mm. The three smaller spot sizes (2x4, 3.5, 5.5 mm) are intended for:

- Benign vascular lesions such as, but not limited to treatment of: port wine . stains, hemangiomas, Warts, superficial and deep telangiectasias (venulectasias), reticular veins (0.1-4.0 mm dia.) of the leg, rosacea, venus lake, leg veins, spider veins, poikiloderma of civatte and angiomas.
- Benign cutaneous lesions, such as, but not limited to: warts, scars, striae . and psoriasis.
- Benign pigmented lesions such as, but not limited to: lentigos (age spots), . solar lentigos (sun spots), cafe-au-lait macules, seborrheic keratosis, nevi and nevus of Ota, chloasma, verrucae, skin tags and keratosis.
- Pigmented lesions to reduce lesion size, for patients with lesions that . would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- The non-ablative treatment of facial wrinkles, such as, but not limited to: . periocular wrinkles and perioral wrinkles.

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- The handpiece with a spot size of 9.5 mm is also is intended for removal of 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 and treatment of pseudofolliculitis barbae (PFB).
#### Predicate Devices:

Substantial equivalence to the following predicate devices is claimed:

| Device Name | 510k No | Date of Clearance |
|--------------------------------------------------------------------------|---------|-------------------|
| Viora Reaction System | K090221 | July 1, 2009 |
| Alma Harmony XL | K113810 | March 8, 2012 |
| OmniMax (Multi-Application<br>Dermatological Treatment<br>device family) | K111303 | Dec 21, 2011 |

#### Substantial Equivalence to Predicate Devices

v The Viora V-total™ includes the ST applicator that is the same applicator that was cleared with the Viora Reaction (K090221) and 3 other applicators: Both

Nd: YAG and IPL applicators are equivalent to the Alma Harmony XL

(K113810) and the Omnimax (K111303). All have the same clinical

indication and use the same technology.

(Handpiece and applicator in this submission have the same meaning).

#### Performance Standards:

V-total™ 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 Medica! Electrical Equipment Part 1-2: . Electromagnetic Compatibility Collateral Standard: -Requirements and Tests.

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

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IEC 60601-2-22 - Medical electrical equipment - Part 2-22: . Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.

IEC 60825-1 - Safety of laser products - Part 1: Equipment . classification, and requirements.

IEC 60601-2-57 - Particular requirements for the basic safety . and essential performance of non-laser light source equipment therapeutic. diagnostic, monitoring intended for and cosmetic/aesthetics

A detailed description appears in Section 14.

#### Performance Bench Tests

Bench testing demonstrated that the V-totalTM is as safe and effective as the cleared predicate devices.

#### Summary of Pre-Clinical and clinical study

The V-total™ is a combination of the cleared Viora Reaction System (K090221 ST applicator), an IPL handpiece and an Nd:YAG handpiece using similar clinical and technological parameters. The safety and efficacy of the Intense Pulse Light (IPL) treatments and Nd:YAG handpiece treatments had been shown by the predicate devices using the same parameters. The clinical safety and efficacy of the ST handpiece has been shown by the Viora Reaction system.

The safety and efficacy of RF bipolar energy treatments as being used by these two applicators are well established in scientific research and literature.

Due to the comprehensive animal and clinical studies already performed by the Viora Reaction (ST Applicator) predicates and other devices, published in scientific literature, and since the power and frequency of the Viora V-total™ are well within the previously cleared Viora Reaction System, Viora believes that animal and clinical studies are not . required to determine the safety and efficacy of the V-totalTM.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract shapes that resemble human figures or flowing lines. The logo is in black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20093-0002

April 9, 2014

Viora Ltd. % Yoram Levy Qsite 31 Haavoda Street Binvamina, 30500 ISRAEL

Re: K133837

Trade/Device Name: Viora V-Total 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: GEX, PBX Dated: March 6, 2014 Received: March 10, 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 cither 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 I hat 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 of uny veith all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Yoram Levy

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 (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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/SafetyReportaProblem/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/Medica]Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133837

Device Name Viora V-Total

#### Indications for Use (Describe)

The Viora V-total™ is intended for dermatological procedures.

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

The 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, rosace, erytherna 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.

The Nd: YAG Laser handpiece with wavelength 1064 mm comes with 4 different applicator spot diameters: 2x4, 3.5 mm. The three smaller spot sizes (2x4, 3.5, 5.5 mm) are intended for:

· Benign vascular lesions such as, but not limited to treatment of: port wine stains, hemangiomas, Warts, superficial and deep telangiecasias (venulectasias), reticular veins (0.1-4.0 mm dia.) of the leg, rosseea, venus lake, leg veins, poikiloderma of civatte and angiomas.

· Benign cutaneous lesions, such as, but not limited to: warts, scars, striae and psoriasis.

· Benign pigmented lesions such as, but not limited to: lentigos (sun spots), cale-aulait macules, sebortheic keratosis, nevi and nevus of Ota, chloasma, verrucae, skin tags and keratosis.

· Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

· The non-ablative treatment of facial wrinkles, such as, but not limited to: periocular wrinkles and perioral wrinkles.

· The handpiece with a spot size of 9.5 mm is also intended for treatment of: Laser skin resurfacing procedures for the treatment of: acne scars and wrinkles. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

• The handpiece with a spot size of 9.5 mm is also is intended for removal of 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 of pseudofolioulitis barber (FFB).

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

[x] Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Neil R Ogo 2014.04.09

FORM FDA 3881 (1/14)

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