NuBrilliance Light Pain Therapy

K150554 · Wellquest International, Inc. · ILY · Oct 6, 2015 · Physical Medicine

Device Facts

• Record ID: K150554
• Device Name: NuBrilliance Light Pain Therapy
• Applicant: Wellquest International, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Oct 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Handheld LED device; emits infrared/red light for therapeutic heating; 4 red diodes (625 nm) and 56 infrared diodes (940 nm). Operator-controlled; no user settings/adjustments; includes internal cooling fan and automatic shut-off safety feature. Used by patients in home setting for temporary pain relief and increased local blood circulation. Device elevates skin temperature via light energy absorption. Clinical decision-making not applicable; device provides symptomatic relief.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance testing, including biocompatibility and electrical safety, and historical market presence of predicate devices.

Technological Characteristics

Handheld LED infrared lamp; 60 total diodes (4 red @ 625nm, 56 infrared @ 940nm); internal cooling fan; automatic shut-off; electrical safety and biocompatibility standards met.

Indications for Use

Indicated for OTC use by adults for muscle relaxation, relief of muscle spasms, temporary relief of minor muscle/joint aches, pains, and stiffness, temporary relief of arthritis-associated pain/stiffness, and temporary increase of local blood circulation.

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

• LED Technologies, LLC DPL™ Therapy System (K081570)

Submission Summary (Full Text)

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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)

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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.

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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#### FOR FDA USE ONLY

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: [phone] Fax: [phone] Contact: Ms. Yveth Kan

#### 2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: [phone] Office Phone: [phone] Fax: [phone] Contact: Carrie Hetrick, Senior Consultant, RA Email: [e-mail]

#### 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

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(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.