ACUBEAM, SUPER NOVA, DIO

K022888 · Light Force Therapy, Inc. · ILY · Dec 11, 2002 · Physical Medicine

Device Facts

• Record ID: K022888
• Device Name: ACUBEAM, SUPER NOVA, DIO
• Applicant: Light Force Therapy, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Dec 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Light-Force-Therapy line of infrared lamps are indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Device Story

Device consists of infrared lamp line (Acubeam, Super Nova, Dio) emitting infrared energy; provides topical heating to elevate tissue temperature. Used for temporary relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, and to promote muscle relaxation and local blood circulation. Operated by user for over-the-counter applications. Output is infrared thermal energy applied to skin surface; effect is localized heating to target tissues.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Infrared lamp emitting energy in the infrared spectrum; Class II device (21 CFR 890.5500); product code ILY.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, muscle relaxation, 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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

: DEC 11 2002

Light Force Therapy, In c/o Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado 80301

Re: K022888

Trade/Device Name: Acubeam, Super Nova, Dio Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Infrared Regulatory Class: Class II Product Code: IL Y Dated: November 30, 2002 Received: December 4, 2002

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

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Page 2 -- Mr. Lewis Ward

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. 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

sincerely yours,

Mark McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Initial 510(k):

Device Name: Infrared Lamp

Indications for Use:

The Light-Force-Therapy line of infrared lamps are indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use | X |
|------------------------------------------|----|----------------------|---|
|------------------------------------------|----|----------------------|---|

for (Division Sign-Off)

Division Restorative

and Neurological Devices

| 510(k) Number | K022888 |
|---------------|---------|
|---------------|---------|