DPL THERAPY SYSTEM

K081570 · Led Technologies, LLC · ILY · Nov 7, 2008 · Physical Medicine

Device Facts

• Record ID: K081570
• Device Name: DPL THERAPY SYSTEM
• Applicant: Led Technologies, LLC
• Product Code: ILY · Physical Medicine
• Decision Date: Nov 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

DPL Therapy System is a compact infrared lamp for therapeutic heating. Device consists of two detachable panels on a desk stand; used individually or as a pair on the body. Device delivers infrared light to skin to elevate local temperature. Features automatic 17-minute timed cycle; reaches target skin temperature in 8 minutes. Operated by user in home or clinical setting. Provides therapeutic heat to relax muscles, relieve spasms, and temporarily increase local blood circulation; aids in temporary relief of minor aches, pains, and stiffness associated with arthritis. Benefits patient through non-invasive thermal therapy.

Clinical Evidence

Clinical studies conducted on male and female subjects demonstrated that therapeutic heat is attained and safe temperatures are maintained for the duration of the 17-minute treatment time. No adverse effects or complications were encountered.

Technological Characteristics

Compact infrared lamp system; two detachable panels on a desk stand. Delivers infrared light for therapeutic heating. Automatic 17-minute timed cycle. Electrical safety: IEC 60601-1-1:2000. Electromagnetic compatibility: EN 60601-1-2:2001.

Indications for Use

Indicated for individuals requiring 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 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

• Dermillume Red HR 1000 (K051681)

Submission Summary (Full Text)

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k081570

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## 510(k) Summary

| Submitted by: | LED Technologies, LLC<br>1460 Conifer Trail<br>Elizabeth, CO 80107<br>USA | | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | NOV - 7 2008 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------------------------------|-------------------------------------------|
| Contact Person: | Lewis Ward<br>L.W. Ward and Associates, Inc.<br>4655 Kirkwood Court<br>Boulder, CO 80301<br>USA | | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Date Prepared: | 10-27-08 | | | |
| Device Trade Name: | Infrared Lamp | | | |
| Classification Name: | Regulation Number: 21 CFR 890.5500<br>Regulation Name: Infrared Lamp | | | Regulation Class: II<br>Product Code: ILY |
| Intended Use: | Intended for the relaxation of muscles and relief of muscle<br>spasms; temporary relief of minor muscle and joint aches,<br>pains, and stiffness; temporary relief of minor pain and<br>stiffness associated with arthritis; and to temporarily<br>increase local blood circulation. | | | |
| Technological<br>Characteristics: | The DPL ^TM Therapy System is a compact infrared lamp for<br>therapeutic heating. It delivers infrared light to the skin resulting in a<br>safe elevation of the skin temperature for therapeutic effects. The<br>device is comparable in design, technology, and output to the<br>Dermillume HR 1000 infrared lamp product. The lamps are contained<br>in two panels on a desk stand. The panels are detachable for use<br>individually or as a pair on the body. The product has an automatic<br>17-minute timed cycle which may be repeated by activating the ON<br>cycle. Device takes 8 minutes to reach target temperature on skin.<br>Total time for treatment is 17 minutes. | | | |
| Substantial Equivalence: | The DPL ^TM Therapy System is substantially equivalent to the<br>Dermillume Red HR 1000 device, 510(k) K051681. The DPL ^TM Therapy<br>System furnishes therapeutic heating comparable to the predicate. | | | |
| Test Data: | The device conforms to the electrical safety requirements established in<br>IEC 60601-1-1:2000 and complies to the electromagnetic compatibility<br>requirements in EN 60601-1-2:2001. Clinical studies demonstrate that<br>therapeutic heat is attained for male and female subjects. Safe temperatures<br>were maintained for the duration of the treatment time. No adverse effects at<br>complications were encountered. The DPL System's device is safe, as<br>effective, and performs comparable to the predicate device. | | | |

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LED Technologies, LLC % L.W. Ward Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301

NOV - 7 2008

Re: K081570

Trade/Device Name: DPL™ Therapy System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 29, 2008 Received: November 3, 2008

Dear Mr. Ward:

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. Lewis Ward

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pestmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance arvers at [phone]. 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/industry/support/index.html.

Sincerely vours.

Mark M. Mckeen

Mark N. Melkerson 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):

Device Name: DPI,™ Therapy System

Indications for Use:

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.

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

AND/OR

Over-the-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neel R. Ople firxm

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number K081570