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.

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.

AI/ML Overview

The provided text describes the Viora V20 System, a medical device, and its substantial equivalence to a predicate device (Viora V-total, K133837). However, the document does not contain the kind of detailed information typically found in a study demonstrating how a device meets specific acceptance criteria based on performance data.

Instead, this document is a 510(k) summary for the FDA, focusing on establishing substantial equivalence to a previously cleared device. It asserts that because the V20 system's technological parameters are "well within" the cleared Viora V-total system and the handpieces are "exactly the same," animal and clinical studies are not required to determine its safety and efficacy.

Therefore, many of the requested categories of information cannot be extracted from this document, as a standalone performance study with detailed acceptance criteria and results is not presented here.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Not explicitly stated as such, but inferred from the claims)	Reported Device Performance (as stated in the document)
Intended Use Equivalence: The V20 system should have the same intended use as the predicate device.	The V20 system and its predicate have the same intended use.
Indications for Use Equivalence: The V20 system's indications for use should be the same as the predicate device.	The V20 system and its predicate have the same indications for use (for ST and IPL Handpieces).
Technological Features Equivalence: The V20 system should have similar technological features to the predicate device.	The V20 system and the predicate device have similar technological features. The V-ST and V-IPL Handpieces are exactly the same as the cleared Viora V-total ST and IPL Handpieces (K133837).
Safety and Effectiveness (No New Issues): Any differences in software and system design should not raise new issues of safety and effectiveness.	"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."
Compliance with Standards: The V20 system must comply with relevant medical electrical equipment standards.	The V20 system complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-57.
Effectiveness (Bench Testing): Bench testing should demonstrate the V20 system is as safe and effective as the cleared predicate devices.	"Bench testing demonstrated that the V20 system is as safe and effective as the cleared predicate devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided. The document states that "animal and clinical studies are not required" to determine safety and efficacy due to technological equivalence. The mention of "performance testing" and "bench testing" does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. Since clinical studies or specific performance evaluations with a "test set" and "ground truth" (in the typical sense of expert review of patient data) were deemed unnecessary for this 510(k) submission, this information is absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Not provided. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an aesthetic and dermatological treatment system (IPL/RF), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical system with handpieces for treatment, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable / Not provided. The basis for clearance relies on substantial equivalence to a predicate device, which implies that the prior device's established safety and efficacy serve as the "ground truth" for the current device's performance claims. No new, specific ground truth creation for the V20 system itself is detailed.

8. The sample size for the training set:

Not applicable / Not provided. This document does not describe the development of a machine learning algorithm or an AI model that would require a training set.

9. How the ground truth for the training set was established:

Not applicable / Not provided. See point 8.

In summary: The provided text is a regulatory submission focused on substantial equivalence. It asserts that the V20 system is substantially equivalent to a previously cleared device (Viora V-total K133837) due to identical intended use, indications for use, and handpiece technology, along with compliance with performance standards and positive bench testing. It explicitly states that clinical studies were not required for this determination, which means the detailed performance study information requested is not present in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with wavy lines representing their hair or head coverings.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

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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 Nameand Address:	Viora Ltd.3 Maskit StreetHerzliya, Israel 46733Israel
Contact Person:	Omri KeslerCOOEmail: omri@vioramed.comPhone Number: +972 9955 1344Fax Number: +972 9955 1345
EstablishmentRegistrationNumber:	3005695724
Date Prepared:	July 29, 2014
Device TradeName(s):	V20 system
Device CommonName:	Multi application RF and IPL device
Classification:	Name: Laser surgical instrument for use in general and plasticsurgery and in dermatology and Electrosurgical cutting andcoagulation device and accessories.Product code: GEX, PBXRegulation No: 21 CFR878.4810, 21CFR878.4400Class: IIPanel: General and plastic surgery devices
PredicateDevice(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.

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.