(158 days)
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No
The document describes a multi-application platform utilizing RF and IPL technologies with different handpieces. There is no mention of AI, ML, image processing, or any data-driven algorithms for diagnosis, treatment planning, or parameter adjustment beyond operator control. The performance studies rely on bench testing and comparison to predicate devices based on technological parameters, not AI/ML performance metrics.
Yes
The device is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation, treatment of moderate inflammatory acne vulgaris, benign pigmented epidermal lesions, cutaneous lesions, and benign cutaneous vascular lesions. These are all therapeutic indications.
No
The provided text explicitly states the device's intended use is for dermatological procedures and treatment of various conditions (e.g., acne, lesions, hair removal, muscle aches), not for diagnosis.
No
The device description clearly outlines a physical system with a main unit (console), handpieces (V-ST, V-IPL, V-Form), and a foot switch, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are all related to dermatological procedures performed directly on the patient's body (muscle aches, pain, circulation, acne, pigmented lesions, vascular lesions, hair removal, cellulite). IVDs are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Description: The device description details a system that applies radiofrequency (RF) and intense pulsed light (IPL) directly to the patient's skin and underlying tissues. This is consistent with a therapeutic or aesthetic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the Viora V20 system, as described, falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, PBX, ISA
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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
1
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.
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.
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) |
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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
and Address: | Viora Ltd.
3 Maskit Street
Herzliya, Israel 4673303
Israel |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Omri Kesler
COO
Email: omri@vioramed.com
Phone Number: +972 9955 1344
Fax Number: +972 9955 1345 |
| Establishment
Registration
Number: | 3005695724 |
| Date Prepared: | September 09, 2015 |
| Device Trade
Name(s): | V20 system |
| Device Common
Name: | Multi application RF and IPL device |
| Classification: | Name: Laser surgical instrument for use in general and plastic
surgery and in dermatology and Electrosurgical cutting and
coagulation device and accessories.
Product code: GEX, PBX, ISA
Regulation No: 21 CFR878.4810, 21CFR878.4400
Class: II
Panel: General and plastic surgery devices |
| Predicate
Device(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.
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.
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.