(94 days)
Not Found
No
The device description and performance studies focus on the physical properties of the LED belt and its heating capabilities, with no mention of AI or ML algorithms for data processing, analysis, or decision-making.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to emit energy... 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," which are all therapeutic effects.
No.
The device's intended use is to provide topical heating for temporary relief of pain and stiffness, not to diagnose a condition.
No
The device description clearly outlines physical hardware components including LED pods, an elastic belt, Velcro, and a power supply. It is a physical device that emits light for therapeutic purposes, not a software-only application.
Based on the provided information, the LightStim for Pain LED Belt is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This device is applied externally to the body.
- The intended use is for topical heating and temporary relief of pain and stiffness. This is a therapeutic purpose, not a diagnostic one.
- The device description details an external LED belt. There is no mention of collecting or analyzing biological samples.
The information clearly describes a device that applies light energy to the body for therapeutic effects, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ILY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, torso, legs, ankles, lower back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter device
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)
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 in the first 5 minutes of the treatment. Temperatures were checked every 5 minutes and fluctuated 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Temperature warmed to 40 degrees centigrade or more on all 3 individuals. Temperatures fluctuated between 40.0 and 41.8 degrees.
Usability Study: 100% of participants correctly self-selected. 97% (32 of 33 participants) correctly answered all 19 questions and demonstrated understanding and use without difficulties.
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
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
1
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/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 (800) 638-2041 or (301) 796-7100 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) | 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) | |||
| 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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3
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: (949) 502-4088 Mobile: (714) 924-0492
Emails: Steve@lightstim.com & Chase@lightstim.com
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
Belt K151333 | LightStim for Pain
K083580 | LightStim Professional
2-Panel Light - (System
#2 for the purposes of
this submission) K150098 |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | LED Intellectual
Properties, LLC | LED Intellectual
Properties, LLC | LED Intellectual
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
LEDs | Minimum: 1 pod
Maximum: 4 pods | Minimum: 1 pod
Maximum: 1 pod | Minimum: 1 pod
Maximum: 2 pods |
| # of LEDs per Pod | 52 | 72 | 565 |
| Min./Max. Treatment
Area (sq. cm) and
size compatibility to
various areas of the
body | Min:
ട് 55
Max: 220
1-4 smaller pods
allows user to adjust
for curved areas of the
body, e.g. legs,
ankles, lower back. | Min: 42
Treats only smaller
single areas of the
body. | Min 1 Pod:
13
Max 1 Pod:
350
Max: 2 Pods: 700
Treats mostly large
flat areas of the body,
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
5
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.