(112 days)
Not Found
No
The document describes a radiofrequency (RF) system with mechanical massage, and there is no mention of AI or ML in the intended use, device description, or performance studies. The system relies on operator-controlled parameters.
Yes
The device is indicated for "temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation," which are therapeutic applications.
No
The provided text describes the Viora V10 system as being intended for dermatological procedures and for temporary relief of muscle aches, pain, spasm, and improvement of circulation, as well as temporary reduction in the appearance of cellulite. These are all therapeutic or aesthetic outcomes, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition or disease.
No
The device description clearly outlines a system with a "Main Unit (console)" and "treatment Handpieces" which are physical hardware components delivering radiofrequency and mechanical vacuum massage. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for dermatological procedures, temporary relief of muscle aches and pain, muscle spasm, improvement of local blood circulation, and temporary reduction in the appearance of cellulite. These are all therapeutic or aesthetic applications performed directly on the patient's body.
- Device Description: The device is described as an RF multi-application platform with handpieces that deliver radiofrequency and mechanical vacuum massage. This is a physical treatment device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to analyze biological samples to provide diagnostic information. This device's function is to apply energy and massage to the body for therapeutic and aesthetic purposes.
N/A
Intended Use / Indications for Use
The Viora V10 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-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
PBX, ISA
Device Description
The Viora V10 system is a RF multi application platform with two available treatment Handpieces:
- V-ST Handpiece Bi-polar radiofrequency (RF) 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Bench testing demonstrated that the V10 system is as safe and effective as the cleared predicate devices.
Since the technological parameters of the Viora V10 system are well within the previously cleared Viora V20 (console and V-ST Handpiece) and Reaction (Bcontour and F-contour applicators) systems, Viora believes that animal and clinical studies are not required to determine the safety and efficacy of the V10 system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Viora V20 system (K142093), Viora Reaction™ system (K090221)
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.
Not Found
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).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2015
Viora Ltd. Omri Kesler Chief Operating Officer 3 Maskit Street 4673303 Herzliya Israel
Re: K150035
Trade/Device Name: V10 system Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX. ISA Dated: March 31, 2015 Received: April 2, 2015
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 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
1
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,
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)
Device Name V10 system
Indications for Use (Describe)
The Viora V10 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-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)
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)
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 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: | May 01, 2015 |
| Device Trade
Name(s): | V10 system |
| Device Common
Name: | Multi application RF device |
| Classification: | Name: Electrosurgical cutting and coagulation device and
accessories
Product code: PBX, ISA
Regulation No: 21CFR878.4400, 21 CFR 890.5660
Class: II
Panel: General and plastic surgery devices |
| Predicate
Device(s): | Viora V20 system (K142093)
Viora Reaction™ system (K090221) |
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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 "VIORA" is the tagline "Shape the Future" in a smaller, lighter font. The logo is black and white.
Device description
The Viora V10 system is a RF multi application platform with two available treatment Handpieces:
- V-ST Handpiece Bi-polar radiofrequency (RF) 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.
Intended use and indication for use statement
The Viora V10 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-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.
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 Reaction™ system | K090221 | July 1st, 2009 |
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Image /page/5/Picture/0 description: The image is a logo for a company called VIORA. The logo consists of the word "VIORA" in a bold, sans-serif font, with the tagline "Shape the Future" underneath in a smaller font. Above the word "VIORA" is a stylized graphic that resembles an infinity symbol with a curved line extending upwards from the left side of the symbol. The logo is simple, modern, and professional.
Substantial Equivalence to Predicate Device
The V10 system console has similar technological characteristics as the predicate device, performance data demonstrate that the differences between the V10 console and the predicate do not raise any new questions of safety and effectiveness. The Viora V10 V-ST Handpiece has the same intended use, the same technological features and the same performance characteristics as the cleared Viora V20 V-ST Handpiece (K142093). The Viora V10 V-Form Handpiece (with BC and FC applicators) and the Viora ReactionTM B-contour and F-contour applicators (K090221) have identical intended use and similar technological features. Any differences in the V-Form Handpiece design do not raise any new questions of safety and effectiveness, as verified by performance testing.
Therefore, the V10 system is substantially equivalent to its predicate devices.
Performance standards
The V10 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.
Performance Bench Tests
Bench testing demonstrated that the V10 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 overall design is clean and modern.
Pre-Clinical and clinical study
Since the technological parameters of the Viora V10 system are well within the previously cleared Viora V20 (console and V-ST Handpiece) and Reaction (Bcontour and F-contour applicators) systems, Viora believes that animal and clinical studies are not required to determine the safety and efficacy of the V10 system.
Conclusion
Based on the technological characteristics of the devices and the intended use, Viora believes that the V10 system and the predicate devices are substantially equivalent. The differences do not raise any new issues of safety or effectiveness.