(105 days)
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No
The document describes a multi-application platform utilizing radiofrequency (RF) and Intense Pulsed Light (IPL) technologies. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The system relies on operator-controlled parameters.
Yes
The device is intended for the treatment of various medical conditions such as muscle aches and pain, muscle spasm, inflammatory acne vulgaris, benign pigmented epidermal lesions, cutaneous lesions including warts, scars and striae, and benign cutaneous vascular lesions, which are therapeutic uses.
No
The device is described as a multi-application platform for dermatological procedures and treatments, such as temporary pain relief, acne treatment, lesion treatment, and hair removal. This indicates it is a therapeutic device, not a diagnostic one, as it aims to treat conditions rather than identify or characterize them.
No
The device description clearly states it is a "RF and IPL multi application platform with two available treatment Handpieces" and a "Main Unit (console)". This indicates it is a hardware-based system with physical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes dermatological procedures, temporary relief of muscle aches and pain, and treatment of various skin conditions and unwanted hair. These are all therapeutic or aesthetic applications performed directly on the patient's body.
- Device Description: The device description details a system using radiofrequency (RF) and intense pulsed light (IPL) applied via handpieces. This is consistent with devices used for physical treatments, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to deliver energy to the body for therapeutic or aesthetic effects.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, PBX
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.
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)
Bench testing demonstrated that the V20 system is as safe and effective as the cleared predicate devices.
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.
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.
Viora V-totalTM (K133837)
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 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
1
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 Name
and Address: | Viora Ltd.
3 Maskit Street
Herzliya, Israel 46733
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: | July 29, 2014 |
| 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
Regulation No: 21 CFR878.4810, 21CFR878.4400
Class: II
Panel: General and plastic surgery devices |
| Predicate
Device(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.