DERMILLUME RED, MODEL HR1000

K051681 · Care Electronics, Inc. · ILY · Jul 27, 2005 · Physical Medicine

Device Facts

• Record ID: K051681
• Device Name: DERMILLUME RED, MODEL HR1000
• Applicant: Care Electronics, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dermillume Red HR1000 infrared lamp is 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

Dermillume Red HR1000 is a compact infrared therapy lamp; delivers high-intensity narrow-band red and near-infrared light to skin surface. Device consists of light unit with narrow-bandwidth LED array, positioning arm, and firmware-based timer. Used to provide therapeutic heat for muscle relaxation, pain relief, and increased local blood circulation. Operated by clinician or patient; light array provides even illumination. Output intensity and spectral output are primary parameters. Benefits include temporary relief of minor aches, pains, and stiffness associated with arthritis or muscle spasms.

Clinical Evidence

Bench testing only. Irradiance levels compared to predicate devices to demonstrate equivalence. No clinical studies performed; document states no significant adverse reactions observed in clinical studies using this technology.

Technological Characteristics

Compact infrared therapy lamp; narrow-bandwidth LED array light source; firmware-controlled exposure timer; positioning arm. Operates via high-intensity narrow-band red and near-infrared light emission.

Indications for Use

Indicated for patients requiring relaxation of muscles, relief of muscle spasms, temporary relief of minor muscle and joint aches, pains, and stiffness, and temporary relief of minor pain and stiffness associated with arthritis. Also indicated to temporarily increase 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

• Biolight PCD (K011355)
• Biobeam (K042813)
• Anodyne Therapy Systems (K931261)
• PremIR 818 (K042532)
• Dermillume Pro1000 (K043575)

Submission Summary (Full Text)

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## 510(k) Summary 2.

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## 510(k) Summary

| Applicant & Submitter: | Care Electronics, Inc. |
|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 4700 Sterling Dr., Suite D<br>Boulder, CO 80301 |
| Phone: | 303-444-2273 |
| Fax: | 303-447-3502 |
| Contact Person: | Thomas Moody |
| Preparation Date: | 6/21/05 |
| Lamp Submitted: | Dermillume Red Lamp |
| Proprietary Name: | Dermillume Red |
| Common Name: | Infrared Therapy Lamp |
| Classification: | Lamp, Infrared; Class II Product code: ILY |
| Predicate Lamps: | Biolight PCD (K011355), Biobeam (K042813), Anodyne<br>Therapy Systems (K931261), PremIR 818 (K042532),<br>Dermillume Pro1000 (K043575) |
| Lamp Description: | The Dermillume Red HR1000 lamp is a compact light source<br>that delivers high intensity narrow band red and near infrared<br>light to the skin surface. The light sources are narrow<br>bandwidth LEDs mounted in an array to give even and safe<br>illumination of skin surfaces. |
| The principal parts of the lamp are a light unit, positioning arm<br>and firmware timer to control duration of exposure. | |
| Intended Use: | The Dermillume Red HR1000 infrared lamp is intended for the<br>relaxation of muscles and relief of muscle spasms, temporary<br>relief of minor muscle and joint aches, pains and stiffness,<br>temporary relief of minor pain and stiffness associated with<br>arthritis, and to temporarily increase local blood circulation. |

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Care Electronics, Inc.

Dermillume Red 501(k) Submission

051681

## 510(k) Summary, contd.

The performance data obtained from bench testing of the Performance Data: Dermillume lamp substantiates that the irradiance at a practicable distance from the skin surface is comparable with the cited predicated lamps.

> The mode of operation, technology and general principles of this lamp are the same as the predicate lamps.

There are no significant adverse reactions observed in clinical studies using this technology. The lamp is safe and efficacious.

The Dermillume Red HR1000 infrared lamp is substantially Substantial Equivalence: equivalent to the cited predicate lamps for spectral output, mode of operation, operating principals as well as general and specific indications for use. Although there are some differences in the source of the emitted light and output intensity, these differences are minor and do not raise new questions of safety or efficacy.

> The Dermillume Red HR1000 infrared lamp is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, representing healing and medicine. The caduceus is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 2005

Mr. Thomas O. Moody President Care Electronics, Inc. 4700 Sterling Drive, Suite D Boulder. Colorado 80301

Re: K051681

Trade/Device Name: Dermillume Red, model HR 1000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: July 8, 2005 Received: July 12, 2005

Dear Mr. Moody:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2- Mr. Thomas O. Moody

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Stypt Rlvodlee

Mark N. Melkerson, MS Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K051681

Lamp Name: Dermillume Red, model HR1000

Indications for Use: The Dermillume Red HR1000 infrared lamp is 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 temporarity increase local blood circulation.

Prescription Use . Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use Yes (21 CFR 807 Subpart C)

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Lamp Evaluation (ODE)

Styt Rurda

ign-Off (Division Division of General, Restorative, and Neurologica! Devices

**510(k) Number** K051681