IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE

K042256 · Usa Laser Biotech, Inc. · ILY · Nov 17, 2004 · Physical Medicine

Device Facts

• Record ID: K042256
• Device Name: IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE
• Applicant: Usa Laser Biotech, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Nov 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ICL IR Heat Lamp Systems are intended 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 and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Device Story

ICL IR Heat Lamp Systems (ICL 15, ICL 60 PLUS, ICL 100 ACTIVO) emit infrared energy to provide topical heating. Device elevates tissue temperature to provide temporary relief of minor muscle/joint pain, stiffness, arthritis pain, or muscle spasms; increases local blood circulation; promotes muscle relaxation. Used in clinical or home settings; operated by clinicians or patients. Output is infrared thermal energy applied to the skin surface. Benefits include non-invasive symptomatic relief of musculoskeletal discomfort.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Infrared lamp system; emits energy in the infrared spectrum for topical heating. Device configurations include various models (ICL 15, ICL 60 PLUS, ICL 100 ACTIVO). Class II device under 21 CFR 890.5500.

Indications for Use

Indicated for patients experiencing minor muscle and joint pain, stiffness, minor arthritis pain, or muscle spasm requiring topical heating for temporary relief and increased 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

• Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179)
• Meditech International Inc BioFlex Professional Therany System (K023621)

Submission Summary (Full Text)

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NOV 17 2004

K042256 1 of 1

## APPENDIX B

## 510(k) PREMARKET NOTIFICATION SUMMARY (per 21 CFR 807.92)

## ICL 15 HFPL System ICL 60 PLUS HFPL System (Models 40, 100 and 250) ICL 100 ACTIVO Scanner System (Models P3 and P6)

#### I. Applicant:

USA Laser Biotech Inc. 10115 Merrimac Road Richmond, VA 23235 Telephone: [phone]

Key Contact: Nelson Marquina, PhD

#### II. Device Name

Proprietary Name:

ICL 15 HFPL System ICL 60 PLUS HFPL System (Models 40, 100 and 250) ICL 100 ACTIVO Scanner System (Models P3 and P6)

| Common / Usual Name: | Infrared Lamp |
|----------------------|---------------------------------|
| Classification Name: | Infrared Lamp (21 CFR 890.5500) |
| Product Code: | ILY |

#### III. Intended Use of the Device

The ICL IR Heat Lamp Systems are intended 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 and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

#### IV. Predicate Devices

The ICL IR Heat Lamp Systems are substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. TThese predicate devices include the Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179) and the Meditech International Inc BioFlex Professional Therany System (K023621).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 17 2004

USA Laser Biotech Inc. C/o Ms. M. Joyce Heinrich Texas Applied Biomedical Services, Inc. 12101 Cullen Boulevard, #A Houston Texas, 77047

Re: K042256

Trade/Device Name: ICL 15 HFPL System ICL 60 Plus HFPL System (Models 40, 100, and 250) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: August 18, 2004 Received: August 24, 2004

Dear Ms. Heinrich:

We have reviewed your Section 510(k) premarket notification of intent to market the device vio have 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 for ass sided in the 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 - Ms. M. Joyce Heinrich

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter notification. The FDA finding of substantial equivalence of your device to a legally prematted predicated. " 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,

Muriam C. Provost

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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### ATTACHMENT I

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Indications for Use

510(k) Number (if known):

K042256

Device Name: ICL 15 HFPL System ICL 60 Plus HFPL System (Models 40, 100 and 250)

Indications for Use:

The ICL IR Heat Lamp Systems, as listed above, are intended 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 and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Prescription Use: _ X AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODpE)

Muriam C. Provost

(Division Sign-Off) Division of General. Restorative. and Neurological Devices

**510(k) Number** K04 2256