Varaya Sport

K150716 · Varaya Photoceuticals, LLC · ILY · Dec 8, 2015 · Physical Medicine

Device Facts

• Record ID: K150716
• Device Name: Varaya Sport
• Applicant: Varaya Photoceuticals, LLC
• Product Code: ILY · Physical Medicine
• Decision Date: Dec 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Handheld therapeutic device; utilizes high-powered LEDs (660nm red, 850nm near-infrared) to distribute light energy. Operated by user via on/off button and control panel for timer/wavelength settings; requires connection to electrical outlet. Held 0.25 inches above treatment area; integrated optics ensure uniform light distribution. Includes safety goggles and power adapter. Recommended treatment: 10-15 minutes. Benefits include pain relief and increased local circulation. Used in home/consumer settings.

Clinical Evidence

No clinical efficacy data provided. Bench testing confirmed compliance with IEC 60601-1, IEC 60601-1-2, and ISO 10993 standards, and FDA tissue temperature heating requirements. OTC use study (self-selection, usability, and label comprehension) conducted with general population sample confirmed device design mitigates risks of misuse and supports appropriate self-selection.

Technological Characteristics

Handheld infrared lamp; utilizes one 660nm red LED and one 850nm near-infrared LED. Integrated optics for uniform light distribution. Powered via electrical outlet. Compliance with IEC 60601-1, IEC 60601-1-2, and ISO 10993. Includes timer and wavelength control panel.

Indications for Use

Indicated for temporary relief of minor muscle/joint pain, arthritis, and muscle spasm; promotion of muscle tissue relaxation; and temporary increase of local blood circulation. Intended for over-the-counter use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Varaya Sport (Model 200) (K112494)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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: | [phone] |
| Fax: | [phone] |

| Contact Person: | Frances Beckman, Co-Owner<br>16511 Scientific Way, Suite 200<br>Irvine, CA 92618 |
|-----------------|----------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Cell: | [phone] |
| Email: | [e-mail] |

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

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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