(216 days)
Not Found
No
The description focuses on the physical components (LEDs, fan, automatic shut-off) and the mechanism of action (light energy for therapeutic heating). There is no mention of any software algorithms, data processing, or learning capabilities. The device is described as having no user settings or adjustments, further indicating a lack of complex computational features typically associated with AI/ML.
Yes
The device is intended for therapeutic uses such as relaxation of muscles, relief of muscle spasms, temporary relief of pain and stiffness, and to increase local blood circulation, which are all therapeutic effects.
No
Explanation: The device is described as a therapy system intended for the relaxation of muscles and relief of pain and stiffness, and to increase local blood circulation. It delivers light energy for therapeutic heating. There is no mention of it being used to diagnose conditions.
No
The device description explicitly states it is a "light emitting diode (LED) device" and a "hand held, ergonomically designed pain relief device" with physical components like diodes, a handle containing electronics, and a fan. This indicates it is a hardware device, not software-only.
Based on the provided information, the Nu Brilliance Light Pain Therapy system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the relaxation of muscles, relief of muscle spasms, temporary relief of minor muscle and joint aches, pains, and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation. These are all therapeutic applications applied directly to the body.
- Device Description: The device is a handheld LED device that emits light energy for therapeutic heating. It is applied externally to the skin.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Nu Brilliance Light Pain Therapy system does not interact with or analyze any bodily specimens.
Therefore, the Nu Brilliance Light Pain Therapy system is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nu Brilliance Light Pain Therapy system is an Over-The-Counter handheld device intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
Product codes
ILY
Device Description
The NuBrilliance Light Pain Therapy device is a lightweight, light emitting diode (LED) device that emits light energy. The NuBrilliance Light Pain Therapy device is an Over-The-Counter (OTC), hand held, ergonomically designed pain relief device that uses the infrared lamp for therapeutic heating. The head consists of four (#4) visible diodes (red lights) in the 625 nm (±5%) spectrum, and (#56) fifty-six infrared diodes (purple lights) in the 940 nm (±5%) spectrum that are used in combination for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature. Treatment is controlled by the operator. There are no user settings or adjustments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Over-The-Counter
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The device has been tested for applicable safety requirements. The NuBrilliance Light Pain Therapy complies with the applicable voluntary standards for biocompatibility. As part of demonstrating safety and effectiveness of NuBrilliance Light Pain Therapy and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Wellquest International, Inc. completed a number of tests. The NuBrilliance Light Pain Therapy meets all the requirements for the overall design, biocompatibility, and electrical safety confirm that the output meets the design inputs and specifications. The NuBrilliance Light Pain Therapy passed all testing stated above as shown by the acceptable results obtained.
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
Key Metrics
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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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a central emblem. The emblem consists of a stylized image of an eagle or bird with three human profiles nested within its wing or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2015
Wellquest International Incorporated % Ms. Carrie Hetrick Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, Texas 78701
Re: K150554
Trade/Device Name: NuBrilliance Light Pain Therapy Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Dated: August 27, 2015 Received: August 28, 2015
Dear Ms. Hetrick:
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS)
1
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.
Sincerelv vours.
Joshua
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K150554
Device Name NuBrilliance Light Pain Therapy
Indications for Use (Describe)
The Nu Brilliance Light Pain Therapy system is an Over-The-Counter handheld device intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary for NuBrilliance Light Pain Therapy K150554
1. Submission Sponsor
Wellquest International, Inc. 230 Fifth Ave. Suite 808 New York, NY 10001 USA Phone: (212) 689.9094 Fax: (212) 213.1599 Contact: Ms. Yveth Kan
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 838.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com
3. Date Prepared
October 5, 2015
4. Device Identification
| Trade/Proprietary Name: | NuBrilliance Light Pain Therapy |
|---|---|
| Common/Usual Name: | Infrared lamp |
| Classification Name: | Infrared lamp |
| Classification Regulation: | 21 CFR § 890.5500 |
| Product Code: | ILY |
| Device Class: | Class II |
| Classification Panel: | Physical Medicine |
5. Legally Marketed Predicate Device(s)
LED Technologies, LLC DPL™ Therapy System (K081570)
6. Device Description
The NuBrilliance Light Pain Therapy device is a lightweight, light emitting diode (LED) device that emits light energy. The NuBrilliance Light Pain Therapy device is an Over-The-Counter
4
(OTC), hand held, ergonomically designed pain relief device that uses the infrared lamp for therapeutic heating. The head consists of four (#4) visible diodes (red lights) in the 625 nm (±5%) spectrum, and (#56) fifty-six infrared diodes (purple lights) in the 940 nm (±5%) spectrum that are used in combination for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature. Treatment is controlled by the operator. There are no user settings or adjustments.
7. Indication for Use Statement
The NuBrilliance Light Pain Therapy system is an Over-The-Counter handheld device intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
8. Substantial Equivalence Discussion
The Wellquest NuBrilliance Light Pain Therapy device utilizes the same technological characteristics and has the same intended use as the K081570 predicate device. The K081570 device emits energy from light-emitting diodes (LED)s with wavelengths of 660 nm and 880 nm. The NuBrilliance Light Pain Therapy device emit energy from light-emitting diodes (LED)s with wavelengths of 625 nm and 940 nm. Both devices provide similar irradiance output to the treatment area. The desired therapeutic effects from both devices are generated by their emissions creating a local increased temperature in the area being treated. Differences between the NuBrilliance Light Pain Therapy device and the predicate do not raise new types of questions regarding the safety and effectiveness when used for the above indications for use.
9. Non-Clinical Performance Data
The device has been tested for applicable safety requirements. The NuBrilliance Light Pain Therapy complies with the applicable voluntary standards for biocompatibility. As part of demonstrating safety and effectiveness of NuBrilliance Light Pain Therapy and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Wellquest International, Inc. completed a number of tests. The NuBrilliance Light Pain Therapy meets all the requirements for the overall design, biocompatibility, and electrical safety confirm that the output meets the design inputs and specifications. The NuBrilliance Light Pain Therapy passed all testing stated above as shown by the acceptable results obtained.
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10. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
It has been shown in this 510(k) submission that the differences, between the NuBrilliance Light Pain Therapy device and the predicate device listed above, do not raise new types of questions regarding safety and effectiveness. Further, the NuBrilliance Light Pain Therapy device utilizes the same type of technology as the predicate device. The NuBrilliance Light Pain Therapy, as designed and manufactured, is determined to be substantially equivalent to the above-listed predicate device.