HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System

K163079 · Healthlight, LLC · ILY · Jun 13, 2017 · Physical Medicine

Device Facts

• Record ID: K163079
• Device Name: HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System
• Applicant: Healthlight, LLC
• Product Code: ILY · Physical Medicine
• Decision Date: Jun 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Intended for the relaxation of muscle spasms, temporary relief of minor muscle and joint aches, pain and stiffness, temporarily relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation. The HealthLight Footbed Model HL-FB is specifically indicated for treatment of the feet and lower legs.

Device Story

HealthLight Footbed LED Light Therapy System (Model HL-FB) is an infrared lamp device; delivers light therapy to feet and lower legs. Device utilizes LED technology to emit infrared light; intended to provide temporary relief of minor muscle/joint pain, stiffness, and muscle spasms; also increases local blood circulation. Operated by user (OTC) or clinician; provides non-invasive therapeutic heat/light energy. Benefits include symptomatic relief of pain and improved circulation in targeted lower extremity areas.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Infrared lamp device; utilizes LED light source for therapeutic heat application. Form factor is a footbed designed for lower extremity treatment. Operates as an over-the-counter (OTC) device. No software or complex algorithms described.

Indications for Use

Indicated for individuals requiring temporary relief of minor muscle/joint pain, stiffness, muscle spasms, or arthritis-related pain, and for increasing local blood circulation in the feet and lower legs.

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.

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

June 13, 2017

HealthLight, LLC % Alexander Henderson Official Correspondent HealthLight, LLC 920 East State Parkway, Suite B Schaumburg, Illinois 60173

Re: K163079

Trade/Device Name: HealthLight Footbed LED Light Therapy System Model HL-FB Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: March 11, 2017 Received: March 16, 2017

Dear Mr. Henderson:

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

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related 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.

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

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

Sincerely. Jennifer R. Stevenson -S3

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

510(k) Number (if known) K163079

Device Name

HealthLight Footbed LED Light Therapy System Model HL-FB.

Indications for Use (Describe)

Intended for the relaxation of muscle spasms, temporary relief of minor muscle and joint aches, pain and stiffness, temporarily relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation.

The HealthLight Footbed Model HL-FB is specifically indicated for treatment of the feet and lower legs.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

2 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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