(261 days)
Not Found
No
The description focuses on LED technology, a timer, and wavelength control, with no mention of AI or ML capabilities.
Yes
The device is described as being indicated for the temporary relief of pain and promotion of relaxation/increased circulation, which are therapeutic claims.
No
The intended use of the device is 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," which are therapeutic purposes, not diagnostic.
No
The device description clearly states it is a handheld device utilizing LEDs and includes hardware components like an on/off button, control panel, integrated optics, goggles, and a power cord/adapter. It is not solely software.
Based on the provided information, the Varava Sport Model 200 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the temporary relief of pain, muscle relaxation, and increased blood circulation. These are therapeutic applications, not diagnostic ones. IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a handheld light therapy device that applies light energy externally to the body. This is consistent with a therapeutic device, not an IVD which would involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Varava Sport Model 200 is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
For the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Product codes
ILY
Device Description
The Varaya Sport Model 200 utilizes high powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs 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 a 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/adapter.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Formal clinical trials were not deemed necessary as device is using same or similar technology and intended use as predicate devices.
Information regarding testing safety and effectiveness in accordance with IEC 60601-1, IEC 60601-1-2 and ISO 10993 were provided.
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.
Warp 10 (K032229), Tanda Pro Restore (K090008), Diomedics PainX 2000 Model 900 (K982546), RXLight (K100213).
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
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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510 (k) Summary of Safety and Effectiveness
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 112494
1. General Information:
| Submitter: | Varaya Photoceuticals, LLC |
|---|---|
| Address: | 16511 Scientific Way, Suite 200 |
| Irvine, CA 92618 | |
| P: 949.753.1482 | |
| F: 949.753.1485 | |
| mykl@ldallc.com |
| Contact Person: | Frances Beckman, Owner |
|---|---|
| C: 949.233.6156 | |
| fbeckman2@cox.net |
Date Prepared:
March 19, 2012
- Names:
Varaya Sport Device Name: Device Model No.: 200
Classification Name: Lamp, Infrared Common Name: LED Light System
Physical Medicine Review Panel:
ILY Product Code:
890.5500 Regulation No.:
3. Predicate Devices:
Warp 10 (K032229), Tanda Pro Restore (K090008), Diomedics PainX 2000 Model 900 (K982546), RXLight (K100213).
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4. Device Description:
The Varaya Sport Model 200 utilizes high powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs 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 a 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/adapter.
5. Indications for Use:
For the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
6. Performance Data:
Based upon analysis, Varaya Photoceuticals, LLC believes there are no significant differences from the predicate devices.
7. Comparison to Predicate Devices:
The intended use and technological characteristics are similar or equivalent to the listed predicates.
8. Summary of Testing:
The Varaya Sport Model 200 meets the required tissue heating requirements (tests provided).
Formal clinical trials were not deemed necessary as device is using same or similar technology and intended use as predicate devices.
Information regarding testing safety and effectiveness in accordance with IEC 60601-1, IEC 60601-1-2 and ISO 10993 were provided.
9. Conclusion:
The Varaya Sport Model 200 meets the safety and efficacy requirements necessary for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 6 2012
Varaya Photoceuticals, LLC % Myk Lum 16511 Scientific Way, Suite 200 Irvine, California 92618
Re: K112494
Trade/Device Name: Varaya AR, Varaya Sport Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: May 09, 2012 Received: May 14, 2012
Dear Myk 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
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Page 2 - Myk Lum
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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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INDICATIONS FOR USE
K112494 510(K) NUMBER:
Varaya Sport Model 200 DEVICE NAME:
INDICATIONS FOR USE:
The Varava Sport Model 200 is indicated/intended 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.
Prescription Use: X (Part 21 CFR 801 Subpart D) and/or
Over-the Counter Use: ____ (21CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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NylRP Admn for mxm
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112494
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