LightStim for Pain LED Belt

K151333 · Led Intellectual Properties, LLC · ILY · Aug 21, 2015 · Physical Medicine

Device Facts

• Record ID: K151333
• Device Name: LightStim for Pain LED Belt
• Applicant: Led Intellectual Properties, LLC
• Product Code: ILY · Physical Medicine
• Decision Date: Aug 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The LightStim for Pain LED Belt is an Over-The-Counter device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

Device Story

Portable LED-based therapeutic heating device; consists of 1-4 LED pods attached to an adjustable elastic Velcro belt. Each pod contains 52 LEDs emitting 630nm, 865nm, and 940nm wavelengths. Powered by external 12V AC/DC supply; features manual on/off switch and 30-minute automatic shut-off timer. Used by consumers in home settings for topical heating. Device elevates skin temperature to 40-41.8°C to provide temporary relief of minor muscle/joint pain, stiffness, arthritis, and muscle spasms, and to increase local blood circulation. User applies belt to target areas (e.g., ankles, torso, legs).

Clinical Evidence

Bench testing only. Electrical safety and performance tested per IEC 60601-1 and IEC 60601-1-2. Temperature testing on 3 individuals confirmed skin warming to 40-41.8°C. Usability study (n=33, ages 20-79) demonstrated 100% correct self-selection and 97% comprehension of instructions and device operation.

Technological Characteristics

Infrared therapeutic heating lamp (21 CFR 890.5500). Emits visible/near-infrared light (630nm, 865nm, 940nm). Output: 60mW/cm2. 1-4 pods, 52 LEDs per pod. Powered by 12V AC/DC supply. Elastic belt form factor with Velcro. Tested to IEC 60601-1 and IEC 60601-1-2 standards.

Indications for Use

Indicated for OTC use by adults for temporary relief of minor muscle/joint pain and stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary muscle relaxation.

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

• LightStim Professional 2-Panel Light System #2 (K150098)
• LightStim for Pain (K083580)

Submission Summary (Full Text)

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August 21, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

LED Intellectual Properties LLC Mr. Steve Marchese Chief Executive Officer 16552 Von Karman Avenue Irvine, California 92606

Re: K151333

Trade/Device Name: LightStim for Pain LED Belt Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: May 17, 2015 Received: May 27, 2015

Dear Mr. Marchese:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 [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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

For

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) K151333

Device Name LightStim for Pain LED Belt

#### Indications for Use (Describe)

The LightStim for Pain LED Belt is an Over-The-Counter device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

| Type of Use (Select one or both, as applicable) | <table><tr><td>Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td>Over-The-Counter Use (21 CFR 806 Subpart C)</td></tr></table> | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 806 Subpart C) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | | | |
| Over-The-Counter Use (21 CFR 806 Subpart C) | | | |

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary of Safety and Effectiveness

LED Intellectual Properties, LLC.

# Device: LightStim for Pain LED Belt K151333

## 1. General Information

Submitter: LED Intellectual Properties, LLC 16552 Von Karman Ave. Irvine, Ca. 92606

Contact Person: Steve Marchese & Chase Marchese Office: [phone] Mobile: [phone]

Emails: [e-mail] & [e-mail]

#### 2. Device name and code

Device Proprietary Name: LightStim for Pain LED Belt

Classification Code and name: ILY OTC Lamp Infrared Therapeutic Heating

#### 3. Predicate Devices

LED Intellectual Properties LLC LightStim Professional 2-Panel Light System #2 (K150098), and LightStim for Pain (K083580)

#### 4. Device Description

The LightStim for Pain LED Belt is a portable device that has between one and four separate LED pods, each of which has 52 LEDs and are attached to a elastic belt that stretches to encircle different sizes from as small as an ankle to as large as the torso, and attaches to itself with Velcro. Each pod has an LED array of 630nm, 865nm, and 940nm. The device is powered by a separate AC to DC 12-volt power supply and has an on/off switch, with a timer that shuts the device off automatically after 30 minutes of operation. Recommended treatment time is 5 to 30 minutes.

#### 5. Indications for Use

The LightStim for Pain LED Belt is an Over-The-Counter device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

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### 6. Substantial Equivalency

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device(s). The LightStim for Pain LED Belt K151333 has the same intended use, is manufactured by the same LED Intellectual Properties, LLC, utilizes the exact same LEDs, has the same power output, and has a similar size treatment area as both predicates (see Summary of Safety & Effectiveness Table below).

| Characteristic | LightStim for Pain LED<br>Belt K151333 | LightStim for Pain<br>K083580 | LightStim Professional<br>2-Panel Light - (System<br>#2 for the purposes of<br>this submission) K150098 |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | LED Intellectual<br>Properties, LLC | LED Intellectual<br>Properties, LLC | LED Intellectual<br>Properties, LLC |
| LED Wavelengths | 630, 660, 855, 940 | 630, 660, 855, 940 | 630, 660, 855, 940 |
| Output in Milliwatts | 60mW cm2 | 60mW cm2 | 60mW cm2 |
| Number of Pods of<br>LEDs | Minimum: 1 pod<br>Maximum: 4 pods | Minimum: 1 pod<br>Maximum: 1 pod | Minimum: 1 pod<br>Maximum: 2 pods |
| # of LEDs per Pod | 52 | 72 | 565 |
| Min./Max. Treatment<br>Area (sq. cm) and<br>size compatibility to<br>various areas of the<br>body | Min:<br>ട് 55<br>Max: 220<br>1-4 smaller pods<br>allows user to adjust<br>for curved areas of the<br>body, e.g. legs,<br>ankles, lower back. | Min: 42<br>Treats only smaller<br>single areas of the<br>body. | Min 1 Pod:<br>13<br>Max 1 Pod:<br>350<br>Max: 2 Pods: 700<br>Treats mostly large<br>flat areas of the body,<br>e.g. the back or chest. |

## 7. Performance Testing

The LightStim for Pain LED Belt results in patient contact with an electrically powered component therefore; it was tested according to 60601-1: Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance

The LightStim for Pain LED Belt includes an electronic component, and it was tested according to 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Safety and Essential Performance.

Temperature testing was performed on 3 individuals. The LightStim for Pain LED Belt warmed the temperature of the skin to 40 degrees centigrade or more on all 3 individuals

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in the first 5 minutes of the treatment. Temperatures were checked every 5 minutes and fluctuated between between 40.0 and 41.8 degrees during the entire 30-minutes test.

A Usability Study was conducted with 33 male and female participants of a variety of races, between the ages of 20 and 79, with education levels varying from 900 grade to 4year college degrees. 100% of the participants correctly self-selected. 97% (32 of the 33 participants) correctly answered all 19 questions relating to the Instruction Manual and correctly demonstrated their understanding and use of the device without any difficulties.

Therefore, taking into consideration the Table for Substantial Equivalence and the Summary of Safety & Effectiveness Table, an analysis of safety, indications, intended uses, performance, and technological properties, the LightStim for Pain LED Belt K151333 raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate devices.