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.

The V-Form Handpiece (with BC and FC applicators) is indicated for delivering non thermal RF combined with massage: relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.

Device Description

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

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

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

V - Form Handpiece (with BC and FC applicators) - mechanical vacuum massage and Bi-polar radiofrequency (RF) 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 does not contain acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) premarket notification for the Viora V20 System, a multi-application RF and IPL device for dermatological procedures. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting performance data from a new study against defined acceptance criteria.

Here's why the requested information cannot be extracted and what is described instead:

Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or report corresponding performance metrics for a new study. Instead, it argues for substantial equivalence by stating that the current device has "the same technological characteristics and the same performance characteristics" as its predicate devices, or that "no new safety or efficacy issues can be raised."
Sample Size and Data Provenance: No new study data is presented, so there is no mention of sample size for a test set or data provenance.
Number and Qualifications of Experts: No experts were used to establish ground truth because no new clinical study data is presented for performance evaluation.
Adjudication Method: Not applicable, as no new study requiring ground truth establishment is described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a 510(k) for a physical medical device, not an AI/ML diagnostic or assistive tool that would typically involve human-in-the-loop studies.
Standalone Performance: Not applicable. The device is a physical system (RF and IPL handpieces) and not an algorithm/software with standalone performance metrics in the typical AI sense.
Type of Ground Truth: Not applicable, as no new performance study data is presented.
Sample Size for Training Set: Not applicable. This refers to an AI/ML training set, which is not relevant to this device's submission type.
How Ground Truth for Training Set was Established: Not applicable.

What the document does state regarding "proof" and "performance":

Substantial Equivalence: The core argument is substantial equivalence to predicate devices (Viora V20 system K142093 and Viora V10 system K150035). The manufacturer asserts that the V20 system with the V-Form Handpiece is "exactly the same" or has "the same technological characteristics and the same performance characteristics" as the cleared predicate devices, thus raising "no new safety or efficacy issues."
Bench Testing: "Bench testing demonstrated that the V20 system (with the V- Form Handpiece) is as safe and effective as the cleared predicate devices." However, specific numerical results or acceptance criteria for this bench testing are not provided in this summary.
No Clinical Studies Required: "Since the technological parameters of the Viora V20 system with the V- Form Handpiece are well within the parameters of the previously cleared V20 and V10 systems, Viora believes that animal and clinical studies are not required to determine the safety and efficacy of the V20 system with the V- Form Handpiece." This explicitly states that no new clinical study (which would typically generate performance data against acceptance criteria) was conducted or deemed necessary for this submission.
Compliance with Standards: The V20 system complies with several IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-57), which demonstrate safety and essential performance through adherence to recognized international standards.

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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, with a flowing, ribbon-like element connecting them.

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

February 19, 2016

Viora Ltd. Omri Kesler Chief Operating Officer 3 Maskit Street Herzliya, ISREAL 4673303

Re: K152611 Trade/Device Name: V20 System Regulation Number: 21 CFR 878.4810 Regulation Name: General and Plastic Surgery Devices Regulatory Class: Class II Product Code: GEX, PBX, ISA Dated: January 18, 2016 Received: January 21, 2016

Dear Omri 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jennifer R. Stevenson -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) K152611

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.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 4673303Israel
Contact Person:	Omri KeslerCOOEmail: omri@vioramed.comPhone Number: +972 9955 1344Fax Number: +972 9955 1345
EstablishmentRegistrationNumber:	3005695724
Date Prepared:	September 09, 2015
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, PBX, ISARegulation No: 21 CFR878.4810, 21CFR878.4400Class: IIPanel: General and plastic surgery devices
PredicateDevice(s):	Viora V20 system (K142093)Viora V10 system (K150035)

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Image /page/4/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 entire logo is in black and white.

Device description

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

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

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

V - Form Handpiece (with BC and FC applicators) - mechanical vacuum massage and Bi-polar radiofrequency (RF) Handpiece.

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.

The V-Form Handpiece (with BC and FC applicators) is indicated for delivering

non thermal RF combined with massage:

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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.

relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and
· temporary reduction in the appearance of cellulite.

Predicade Devices

Substantial equivalence to the following predicate devices is claimed:

Device Name	510k No.	Date of Clearance
Viora V20 system	K142093	November 14, 2014
Viora V10 system	K150035	May 1, 2015

Substantial Equivalence to Predicate Device

The V20 system with the V- Form Handpiece and its predicate devices have the same intended use and the same indications for use. The proposed V-ST and V-IPL Handpieces have the same technological characteristics and the same performance characteristics as the cleared Viora V20 V-ST and V-IPL Handpieces (K142093). Therefore, no new safety or efficacy issues can be raised.

The Viora V20 V-Form Handpiece is exactly the same as the cleared Viora V10 V-Form Handpiece (K150035). The V-Form Handpiece has the same technological characteristics and the same performance as the predicate device. Therefore, no new safety or efficacy issues can be raised.

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 with the V- Form Handpiece is substantially equivalent to its 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.

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 (with the V- Form Handpiece) is as safe and effective as the cleared predicate devices.

Pre-Clinical and clinical study

Since the technological parameters of the Viora V20 system with the V- Form Handpiece are well within the parameters of the previously cleared V20 and V10 systems, Viora believes that animal and clinical studies are not required to determine the safety and efficacy of the V20 system with the V- Form Handpiece.

Conclusion

Based on the technological characteristics of the devices and the intended use, Viora believes that the V20 system with the V- Form Handpiece and the predicate devices 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.