(264 days)
Not Found
No
The device description and performance studies focus on light therapy technology and standard electrical/software safety testing, with no mention of AI or ML capabilities.
Yes
The device description explicitly states, "The Varaya Sport (Model 200) is a therapeutic device..." Additionally, its intended use for temporary relief of pain and promotion of relaxation and blood circulation aligns with therapeutic functions.
No
The device is described as a "therapeutic device" intended for "temporary relief of minor muscle and joint pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation." Its purpose is to treat symptoms, not to diagnose a medical condition.
No
The device description explicitly states it is a therapeutic device utilizing high-powered Light Emitting Diodes (LEDs) and is handheld, requiring connection to an electrical outlet. This indicates it is a hardware device with integrated software for control.
Based on the provided information, the Varaya Sport Mode 200 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the temporary relief of pain, muscle relaxation, and increased blood circulation. This is a therapeutic use applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device uses LEDs to deliver light energy to the skin. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Varaya Sport Mode 200 does not fit this description.
N/A
Intended Use / Indications for Use
The Varaya Sport Model 200 is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The Varaya Sport (Model 200) is a therapeutic device utilizing high-powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs in the device are: one visible Red (660nm) and one invisible nearInfrared (850nm). The device is handheld .25" above the desired treatment area and operates when connected to an electrical outlet. The device has an on/off button and control panel for a built-in timer and wavelengths. The device has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adaptor. Recommended treatment time is 10-15 minutes per use.
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
Over-The-Counter Use
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical and Clinical Testing:
The subject device has been tested to confirm compliance in accordance with IEC 60601-1 (200 Edition), IEC 60601-1-2 and ISO 10993 standards. The subject device has been tested to confirm compliance per FDA required tissue temperature heating requirement. The subject software has been fully validated per FDA requirement for software validation. These test results serve to confirm that the Varava Sport (Model 200) does not raise any new issues of safety or effectiveness.
Over-the Counter Use Study:
Varaya Photoceuticals, LLC has performed the OTC Use Study (self-selection, usability and label comprehension) to ensure the understanding of the proper use as well as any risks of misuse of the Varaya Sport (Model 200) as an over-the-counter medical device product. Study participants were recruited solely from the general population, not specifically from a group of intended consumers. This was done to ensure an unbiased, naive sample representative of the general US population. The study data shows that the device design essentially mitigates anticipated risks of misuse and misunderstanding of the instruction for use. The self-selection protocol and results confirmed a person was able to appropriately self-select themselves into using or rejecting the device.
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.
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
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
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Image /page/0/Picture/1 description: The image contains the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol consisting of three overlapping human profiles facing to the right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Varaya Photoceuticals, LLC Mr. Myk Lum Co-owner 16511 Scientific Way, Suite 200 Irvine, California 92618
December 8, 2015
Re: K150716 Trade/Device Name: Varaya Sport (Model 200) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: October 20, 2015 Received: November 2, 2015
Dear Mr. Lum,
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
For
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Joshua C. Nipper -S
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) K150716
Device Name Varaya Sport Model 200
Indications for Use (Describe)
The Varaya Sport Mode 200 is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
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/1 description: The image shows the logo for Varaya Pharmaceuticals. The logo features an orange, four-petal flower-like design above the word "varaya" in lowercase, followed by the word "photoceuticals" in a smaller font size. The overall design is clean and modern.
entific Way, Suite 200
PHOTOCEUTICALS, LLC
510(k) Summary of Safety and Effectiveness
This traditional 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Owner's Name: | Varaya Photoceuticals, LLC |
|---|---|
| Address: | 16511 Scientific Way, Suite 200 |
| Irvine, CA 92618 | |
| Telephone: | (949) 753-1482 |
| Fax: | (949) 753-1485 |
| Contact Person: | Frances Beckman, Co-Owner
16511 Scientific Way, Suite 200
Irvine, CA 92618 |
|-----------------|----------------------------------------------------------------------------------|
| Telephone: | (949) 743-1482 |
| Fax: | (949) 753-1485 |
| Cell: | (949) 233-6156 |
| Email: | fbeckman2@cox.net |
510(k) preparation date: March 11, 2015
Device Name and Classification:
| Trade and Proprietary name: | Varaya Sport (Model 200) |
|---|---|
| Common Name: | Infrared Lamp |
| Classification Name: | Lamp Infrared, Therapeutic Heating |
| Product Code: | ILY |
| Regulation Number: | 21 CFR 890.5500 |
| Class: | II |
Predicate Device:
The legally marketed predicate for the Varaya Sport (Model 200) is: K112494, Varaya Sport (Model 200).
Device Description:
The Varaya Sport (Model 200) is a therapeutic device utilizing high-powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs in the device are: one visible Red (660nm) and one invisible nearInfrared (850nm). The device is handheld .25" above the desired treatment area and operates when connected to an electrical outlet. The device has an on/off button and control panel for a built-in timer and wavelengths. The device
4
has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adaptor. Recommended treatment time is 10-15 minutes per use.
Intended Use:
The Varaya Sport Model 200 is indicated/intended for the temporary relief of minor muscle and join pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Technological Characteristics:
This submitted device is the same device as in K112494 (predicate) with no technological changes. The Varaya Sport (Model 200) device utilizes two highpowered LEDs: one Red and one nearInfrared in a handheld unit. The device is held .25" above the desired treatment area and operated when connected to an electrical outlet. The device has an on/off button and control panel for a built-in timer and wavelengths. The device has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adaptor.
Nonclinical and Clinical Testing:
The subject device has been tested to confirm compliance in accordance with IEC 60601-1 (200 Edition), IEC 60601-1-2 and ISO 10993 standards. The subject device has been tested to confirm compliance per FDA required tissue temperature heating requirement. The subject software has been fully validated per FDA requirement for software validation. These test results serve to confirm that the Varava Sport (Model 200) does not raise any new issues of safety or effectiveness.
Over-the Counter Use Study:
Varaya Photoceuticals, LLC has performed the OTC Use Study (self-selection, usability and label comprehension) to ensure the understanding of the proper use as well as any risks of misuse of the Varaya Sport (Model 200) as an over-thecounter medical device product. Study participants were recruited solely from the general population, not specifically from a group of intended consumers. This was done to ensure an unbiased, naive sample representative of the general US population. The study data shows that the device design essentially mitigates anticipated risks of misuse and misunderstanding of the instruction for use. The self-selection protocol and results confirmed a person was able to appropriately self-select themselves into using or rejecting the device.
End of 510(k) Summary