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).

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 .

AI/ML Overview

The Viora V-total™ device is a multi-application, multi-technology platform for dermatological procedures.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or a specific table with reported device performance metrics in the format usually seen for medical devices with measurable performance outcomes (e.g., sensitivity, specificity, accuracy for diagnostic devices).

Instead, the submission for V-total™ relies on demonstrating substantial equivalence to previously cleared predicate devices. The "acceptance criteria" are implied to be that the V-total™ is as safe and effective as the predicate devices and complies with relevant safety standards.

Acceptance Criteria (Implied)	Reported Device Performance
As safe and effective as cleared predicate devices	Claimed substantial equivalence based on similar clinical and technological parameters and established safety/efficacy of predicate devices.
Compliance with relevant safety standards (IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-22, 60825-1, 60601-2-57)	Explicitly states: "V-total™ complies with" all listed IEC standards.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states that no new animal or clinical studies were conducted for the Viora V-total™ device to determine its safety and efficacy. Therefore, there is no "test set" in the traditional sense for this submission. The basis for safety and efficacy relies entirely on the established performance of the predicate devices.

Sample Size for Test Set: Not applicable (no new clinical studies performed).
Data Provenance: Not applicable (reliance on existing data from predicate devices and scientific literature, not new data from this device).

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:

Since no new clinical studies were performed for the V-total™ device, there were no experts recruited specifically to establish ground truth for a test set related to this submission. The ground truth for the predicate devices' studies would have been established by medical professionals in those respective studies.

4. Adjudication Method for the Test Set:

Not applicable, as no new clinical test set was used for the V-total™ device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or referenced for this device. The device is a physical therapy/aesthetic device, not a diagnostic imaging device that would typically involve human readers interpreting results.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a treatment system that requires operation by a human professional (practitioner) and does not involve an "algorithm only" performance that can be evaluated separately from human interaction in a diagnostic sense.

7. Type of Ground Truth Used:

The "ground truth" for the V-total™'s safety and efficacy claims is implicitly based on:

Clinical Efficacy/Outcomes Data from Predicate Devices: The submission relies on the established clinical results, safety profiles, and indications for use of the predicate devices for their respective technologies (ST applicator, IPL, Nd:YAG laser). These predicate devices would have undergone their own studies where treatment outcomes (e.g., hair reduction, lesion clearance, muscle pain relief) served as the ground truth.
Scientific Literature: The document mentions that the safety and efficacy of RF bipolar energy treatments are "well established in scientific research and literature."

Therefore, the ground truth is essentially derived from previously established clinical outcomes and scientific consensus through the predicate device pathway.

8. Sample Size for the Training Set:

Not applicable. The V-total™ is not an AI/machine learning model where a "training set" would be used to develop an algorithm. Its development relies on established engineering principles and the existing designs/technologies of identified predicate devices.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device in the context of an AI/ML model.

Summary

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Image /page/0/Picture/1 description: The image shows the word "VIORA" in a serif font. Above the word is a stylized graphic that resembles an infinity symbol or a decorative flourish. The text is in all caps and appears to be a logo or brand name.

510(K) SUMMARY

V-total™M

510(k) Number K133837

Applicant's Name:	Viora Ltd.3 Maskit StreetHerzliya, Israel 46733Tel: +972 9955 1344Fax: +972 9955 1345
Contact Person:	Yoram Levy, Qsite31 Haavoda StreetBinyamina, Israel 30500Tel (972)4-638-8837; Fax (972)4-638-0510Yoram@qsitemed.com
Trade Name:	V-total TM
SummaryPreparation 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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Image /page/1/Picture/0 description: The image shows the word "VIORA" in large, bold letters, with a stylized graphic above it. Below the word "VIORA" is the phrase "Intended Use Statement:". The text is black and the background is white.

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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Image /page/2/Picture/0 description: The image shows the word "VIORA" in a serif typeface. Above the word is a stylized graphic that looks like a loop with a line extending from the top. The graphic is positioned directly above the letters "VIO" of the word "VIORA". The image is black and white.

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-ApplicationDermatological Treatmentdevice 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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Image /page/3/Picture/0 description: The image shows the word "VIORA" in a serif font, with a stylized graphic above it. The graphic appears to be a loop or knot-like design, possibly representing an infinity symbol or a stylized letter. The text is in all caps and is the primary focus of the image.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.