(224 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and heating capabilities of the LED bed, with no mention of AI or ML algorithms for data processing, analysis, or decision-making.
Yes
The device is intended to provide topical heating for the temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles, which are all therapeutic claims.
No
The device description and intended use state that it emits energy to provide topical heating for pain relief and circulation, and the performance studies measure skin temperature response to the device. There is no mention of it diagnosing any medical conditions; rather, it is used for therapeutic purposes.
No
The device description clearly outlines a physical hardware device (LED bed, LEDs, power supply, on/off switch) and performance studies involve measuring skin temperature using a physical thermometer, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating for temporary relief of pain, stiffness, muscle spasm, increased blood circulation, and muscle relaxation. These are all therapeutic effects applied to the body, not diagnostic tests performed on samples taken from the body.
- Device Description: The description details a physical bed-like device with LEDs that emit light. This aligns with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The LightStim Professional LED Bed is an over-the-counter device intended to emit energy in the visible and IR spectrum intended 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
ILY
Device Description
The LightStim Professional LED Bed is a device that is similar in design to the bottom half of a tanning bed. It is approximately 6.5 feet in length and 3 feet wide. It has 18,240 LEDs. There is an on/off switch that turns off after 30 minutes of use, and an AC to DC power supply.
The LightStim Professional LED Bed is intended to be operated only by a person who has been personally trained by Company personnel. Each LED Bed includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the LED Bed with the end user.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The LightStim Professional LED Bed device was tested using the same skin temperature testing as all of the predicate devices. The participants skin temperature was measured on six different locations of the body prior to using the device, then each body location was rechecked four times at 3-minute intervals and once at the end of the 30-minute test period. All of the participants skin temperature fluctuated between 40-41.3 degrees centigrade during the 30-min temperature test, which is within the FDA guidelines for the ILY category, and those readings were almost identical to the readings of the predicate devices, which used the same procedure. Temperature readings were measured using the same device that was used for the predicate devices, a "Mastercool, Infrared Laser Thermometer".
As the same temperature testing procedure was conducted, using the same thermometer, and achieving almost identical results as all three predicate devices, the LightStim Professional LED Bed raises no new issues of safety or effectiveness.
The LightStim Professional LED Bed device results in patient contact with an electrically powered component therefore; it was tested for conformance to IEC / EN 60601-1 3rd Edition: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
The LightStim Professional LED Bed device includes an electronic component, and it was tested for conformance to IEC / EN 60601-1-2 3rd Edition Medical Electrical Equipment - Part 1-2: General Requirements for Safety and Essential Performance-Collateral standard: Electromagnetic compatibility-Requirements and tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three faces in profile, stacked on top of each other. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 5, 2016
Led Intellectual Properties LLC Mr. Steve Marchese CEO 16552 Von Karman Ave Irvine, California 92606
Re: K153399
Trade/Device Name: LightStim Professional Led Bed Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: June 14, 2016 Received: June 14, 2016
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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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
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For 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 Statement
| 510(k) Number (if known) | K153399 |
|---|---|
| Device Name | LightStim Professional LED Bed |
| Indications for Use | The LightStim Professional LED Bed is an over-the-counter device intended to emit energy in the visible and IR spectrum intended 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. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801. 109) OR
X Over-The-Counter Use
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510(k) Summary of Safety and Effectiveness
LED Intellectual Properties, LLC.
Device: LightStim Professional LED Bed
1. General Information
Submitter: LED Intellectual Properties, LLC 16552 Von Karman Ave. Irvine, Ca. 92606
Contact Person: Steve Marchese & Chase Marchese Phone: Steve (949) 502-4088 Chase (714) 924-0492
Emails: Steve@lightstim.com & Chase@lightstim.com
2. Device name and code
Device Proprietary Name: LightStim Professional LED Bed
Classification Code and name: ILY - Infrared Lamp, Therapeutic Heating
3. Predicate Devices
LED Intellectual Properties LLC: Pain Therapy Light (K083580, LightStim Professional 2-Panel Light (K150098), LightStim LED Belt (K151333)
4. Device Description
The LightStim Professional LED Bed is a device that is similar in design to the bottom half of a tanning bed. It is approximately 6.5 feet in length and 3 feet wide. It has 18,240 LEDs. There is an on/off switch that turns off after 30 minutes of use, and an AC to DC power supply.
The LightStim Professional LED Bed is intended to be operated only by a person who has been personally trained by Company personnel. Each LED Bed includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the LED Bed with the end user.
5. Indications for Use
The LightStim Professional LED Bed is an over-the-counter device intended to emit energy in the visible and IR spectrum intended 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
| Characteristic | LightStim for Pain
(K083580) | LightStim LED Belt
(K151333) | LightStim Professional 2-
Panel Light (K150098) | LightStim Professional LED
Bed |
|------------------------------------------------------|------------------------------------|---------------------------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Output in milliwatts | 60mW cm2 | 60mW cm2 | System #2 = 60mW cm2 | 60mW cm2 |
| Treatment Time | 5-30 minutes | 5-30 minutes | System #2 = 5-30 minutes | 5-30 minutes |
| Wavelengths (nm) | 630nm, 660nm, 855nm,
940nm | 630nm, 660nm, 855nm,
940nm | System #2 = 630nm, 660nm,
855nm, 940nm | 630nm, 660nm, 855nm, 940nm
Procured from the same
manufacturer with the exact same
specifications as all three of the |
| Manufacturer | LED Intellectual Properties | LED Intellectual Properties | LED Intellectual Properties | LED Intellectual Properties |
| Basic Safety+Performance
Electronic Compatibility | IEC/EN 60601-1
IEC/EN 60601-1-2 | IEC/EN 60601-1 3rd
edition | IEC/EN 60601-1 3rd Edition
IEC/EN 60601-1-2 | IEC/EN 60601-1 3rd Edition
IEC/EN 60601-1-2 |
| Radiation Safety | IEC-62471 | IEC-62471 | IEC-62471 | IEC-62471 |
| FDA Clearance | OTC | OTC | OTC | OTC |
Device Technological Characteristics Comparrison Table
The Conclusion drawn by LED intellectual Properties, LLC based on the table above, is that the LightStim Professional LED Bed is substantially equivalent to the predicates devices and raises of safety or effectiveness.
7. Performance Testing
The LightStim Professional LED Bed device was tested using the same skin temperature testing as all of the predicate devices. The participants skin temperature was measured on six different locations of the body prior to using the device, then each body location was rechecked four times at 3-minute intervals and once at the end of the 30-minute test period. All of the participants skin temperature fluctuated between 40-41.3 degrees centigrade during the 30-min temperature test, which is within the FDA guidelines for the IL Y cateqory, and those readings were almost identical to the readings of the predicate devices, which used the same procedure. Temperature readings were measured using the same device that was used for the predicate devices, a "Mastercool, Infrared Laser Thermometer".
As the same temperature testing procedure was conducted, using the same thermometer, and achieving almost identical results as all three predicate devices, the LightStim Professional LED Bed raises no new issues of safety or effectiveness.
The LightStim Professional LED Bed device results in patient contact with an electrically powered component therefore; it was tested for conformance to IEC / EN 60601-1 3° Edition: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
The LightStim Professional LED Bed device includes an electronic component, and it was tested for conformance to IEC / EN 60601-1-2 3ª Edition Medical Electrical Equipment - Part 1-2: General Requirements for Safety and Essential Performance-Collateral standard: Electromagnetic compatibility-Requirements and tests.
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Therefore, taking into consideration the Table for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the LightStim Professional LED Bed raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate devices.