CS1000 LIGHT THERAPY DEVICE

K110558 · Genesis Health Light Corporation · ILY · Jul 12, 2012 · Physical Medicine

Device Facts

• Record ID: K110558
• Device Name: CS1000 LIGHT THERAPY DEVICE
• Applicant: Genesis Health Light Corporation
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Genesis Health Light's CS1000 Light-based heat Therapy Device is a hand held device used for the treatment of pain by emitting energy in the near IR spectrum for the temporary relief of minor muscle and joint pain, and muscle spasm; relieving stiffness, promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Device Story

Hand-held infrared lamp; utilizes near-IR spectrum energy for heat therapy. Components include motor, fan, light bulb, lens, and plastic injection-molded housing; cooling liquid contained within lens assembly. Plugs into standard 120V outlet. Operated by user for self-treatment of minor muscle/joint pain, spasms, and stiffness. Device emits heat to skin surface (40°-45°C); promotes local blood circulation and muscle relaxation. Provides non-invasive, localized thermal therapy.

Clinical Evidence

Bench testing only. Performance test measured skin surface temperature on 7 subjects with varying skin tones. High power setting reached 40°C in 3-4 minutes; low power setting in 8-9 minutes. Maximum temperature did not exceed 42°C over 20 minutes. Skin tone did not impact surface temperature.

Technological Characteristics

Hand-held infrared lamp; near-infrared light source; plastic injection-molded housing; lens assembly with internal cooling liquid; 120V AC power source. No software or complex algorithms.

Indications for Use

Indicated for temporary relief of minor muscle and joint pain, muscle spasm, and stiffness; promotion of muscle relaxation; and temporary increase of local blood circulation. Intended for over-the-counter use.

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

• Quantum WARP 10 Light Delivery System (K032229)
• Narrow Band, Near-IR Energy Pain Therapy Devices (K042813)

Submission Summary (Full Text)

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Genesis Health Light Corporation Traditional 510(k)

Appendix 4: 510(k) Summary

# 510(k) Summary

JUL 12 2012

| Manufacture Name: | Genesis Health Light Corporation |
|-------------------|----------------------------------------------|
| Contact Name: | Tony Galipeau |
| Postal Address: | 7 Innovation Drive, Hamilton, ON, L9H<br>7H9 |
| Phone Number: | 905 570 4102 |
| Fax: | 905 331 3108 |
| Title: | President & CEO |
| Date: | May 10, 2012 |

| Device Proprietary Name: | CS1000 Light-based heat Therapy Device |
|------------------------------|----------------------------------------|
| Device Common or Usual Name: | Infrared Lamp |
| Classification Name: | Lamp, Infrared |
| Classification Code: | 89 ILY |
| Regulation Number: | 21 CFR 890.5500 |

#### Predicate Devices:

Substantial equivalence is claimed to the following devices.

| Name of Device | Manufacturer | Predicate<br>Comparison | 510(k) Number |
|---------------------------------------------------------|---------------------------|-------------------------------------------|---------------|
| Quantum WARP 10<br>Light Delivery<br>System | Quantum Devices,<br>Inc. | Intended Use,<br>technology,<br>materials | K032229 |
| Narrow Band, Near-<br>IR Energy Pain<br>Therapy Devices | Life Without Pain,<br>LLC | Intended Use,<br>technology,<br>materials | K042813 |

### Description of the Device

Genesis Health Light's CS1000 Light-based heat Therapy Device is a hand held device used for the treatment of pain. The primary components of the device are a motor and fan, light bulb, lens and the plastic injection molded housing which encapsulates the device. Cooling liquid is located within the lens assembly. An electric cable is attached to the internal workings of the device and it plugs into a standard 120V electrical outlet to power the device.

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Genesis Health Light Corporation Traditional 510(k)

### Intended Use/Indications for Use

Genesis Health Light's CS1000 Light-based heat Therapy Device is a hand held device used for the treatment of pain by emitting energy in the near IR spectrum for the temporary relief of minor muscle and joint pain, and muscle spasm; relieving stiffness, promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

#### Technological Characteristics

The subject and predicate devices are hand held electrical devices which utilize near infra red light therapy to relieve pain.

#### Substantial Equivalence Discussion

Predicate devices are the Quantum WARP 10 Light Delivery System, 510(k) K03229 and the Narrow Band, Near-IR Energy Pain Therapy Devices, 510(k) K042813. The subject and predicate devices are equivalent in terms of intended use, technology and materials.

Summary of Performance Test of Skin Surface Temperature

A performance test of skin surface temperature identified that Genesis Health Light's CS1000 device is capable of heating the skin surface to 40°-45°C. There were 7 people with light and dark skin color tone collected to measure the skin surface temperature during lighting with CS1000 device. In high power setting, the skin temperature takes 3-4 minutes to get 40°C, while 8-9 minutes when it is in low power setting. The measurement was performed every minute with a laser temperature reader till 20 minute. Over the entire test period, the temperature doesn't exceed 42°C. The skin color tone doesn't impact skin surface temperature.

#### Conclusion

Based on the information provided in this 510(k) premarket notification, the CS1000 Light-based Heat Therapy Device is substantially equivalent in terms of safety and effectiveness to the predicate devices identified above.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Genesis Health Light Corporation % Mr. Tony Galipeau 7 Innovation Drive Suite 102 Hamilton, Ontario,Canada L9H 7H9

## JUL 12 2012

Re: K110558

Trade/Device Name: CS1000 Light Therapy Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: June 29 2012 Received: July 02 2012

### Dear Mr. Galipeau:

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

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Page 2 - Mr. Tony Galipeau

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Dothmoth
Dexter

Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Genesis Health Light Corporation Traditional 510(k)

## Indications for Use

510(k) Number:

Device Name:

CS1000 Light Therapy Device

Indication for Use:

Genesis Health Light's CS1000 Light Therapy Device is a hand held device used for the treatment of pain by emitting energy in the near IR spectrum for the temporary relief of minor muscle and joint pain, and muscle spasm; relieving stiffness, promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

V Over the Counter Use _ (21 CFR Part 801 Subpart C)

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Concurrence of CDRH

Division Sign-Off

Office of Device Evaluation

510(k) K110558