MLT-1000 IR LASER SYSTEM

K033986 · Medical Laser Therapeutics LP · ILY · Mar 29, 2004 · Physical Medicine

Device Facts

• Record ID: K033986
• Device Name: MLT-1000 IR LASER SYSTEM
• Applicant: Medical Laser Therapeutics LP
• Product Code: ILY · Physical Medicine
• Decision Date: Mar 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MLT - 1000 IR Laser System is 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

MLT-1000 IR Laser System is a hand-held, non-invasive therapeutic device providing continuous heat therapy. System comprises a control unit housing electronics/controls and a treatment probe handpiece. Device emits infrared energy to elevate tissue temperature. Used for temporary relief of minor muscle/joint pain, stiffness, arthritis pain, or muscle spasm; increases local blood circulation; promotes muscle relaxation. Operation involves applying infrared energy topically to the affected area. Healthcare providers use the device to deliver therapeutic heat, potentially benefiting patients through pain reduction and muscle relaxation.

Clinical Evidence

No clinical data. Evidence is based on functional performance and electrical safety testing in accordance with applicable standards for infrared therapeutic lamps, demonstrating substantial equivalence to predicate devices.

Technological Characteristics

Hand-held device utilizing infrared and visible laser diodes for energy emission. Consists of a control unit and treatment probe. Operates as an infrared lamp (21 CFR 890.5500).

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain, stiffness, minor arthritis pain, or muscle spasm; temporary increase in local blood circulation; and promotion of muscle relaxation.

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

• Bales Scientific, Inc. Photonic Stimulator (K974468)
• Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179)
• Meditech International Inc BioFlex Professional Therapy System (K023621)
• Spectrum Laser & Technologies, Inc. Neurolase Series (K032787)

Submission Summary (Full Text)

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K033986

MAR 2 9 2004

# APPENDIX B

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

# MLT - 1000 IR Laser System

## Applicant: ا.

Medical Laser Therapeutics LP 1019 Dragon Street Dallas, Texas 75207 1 214 748 - 1088

Contact Person: James Nairne

December 22, 2003 Date Prepared:

## Device Name ll.

MLT - 1000 IR Laser System Proprietary Name: Infrared Lamp Common / Usual Name: Infrared Lamp (21 CFR 890.5500) Classification Name: ILY Product Code:

## lll. Intended Use of the Device

The MLT - 1000 IR Laser System is 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 MLT-1000 IR Laser System is substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. These predicate devices include, but are not limited to, the Bales Scientific. Inc. Photonic Stimulator (K974468), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), the Meditech International Inc BioFlex Professional Therapy System (K023621) and the Spectrum Laser & Technologies, Inc. Neurolase Series (K032787).

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## V. Description of the Device

The MLT - 1000 IR Laser System is an innovative, safe, easy to use, hand-held, non-invasive therapeutic device that provides continuous heat therapy. The System consists of a Control Unit that houses the electronics and controls and a treatment probe hand piece that delivers the infrared energy.

## Summary of the technical characteristics of the MLT - 1000 IR Laser VI. System to the referenced predicate devices

The MLT - 1000 IR Laser System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and ioint pain.

### VII. Testing

Testing of the MLT - 1000 IR Laser System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device.

#### VIII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the MLT-1000 has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" around the perimeter. Inside the circle is a stylized graphic of three abstract shapes that resemble human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2004

Medical Laser Therapeutics LP c/o Ms. M. Joyce Heinrich Texas Applied Biomedical Services 12101-A Cullen Boulevard Houston, Texas 77047

Re: K033986

Trade/Device Name: MLT -- 1000 IR Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: December 22, 2003 Received: December 30, 2003

## Dear Ms. Heinrich:

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 - Ms. M. Joyce Heinrich

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,

Miriam 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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## APPENDIX C

# STATEMENT OF INDICATIONS FOR USE

ن جي

510(k) Number (if known):

Pending

KO 33986

Device Name:

MLT - 1000 IR Laser System

## Indications for Use:

The MLT - 1000 IR Laser System is 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use:<br>(Per 21 CFR 801.109) | <div style="text-align:left;">✓</div> | OR | Over the Counter Use:<br>(Optional Format 1-2-96) |
|-------------------------------------------|---------------------------------------------------------------|----|---------------------------------------------------|
| (Division Sign-Off) | Miriam C. Provost | | |
| | (Division Sign-Off) | | |
| 510(k) Number | Division of General, Restorative,<br>and Neurological Devices | | |

510(k) Premarket Notification MLT-1005 MUL(k) sheamber________________________________________________________________________________________________________________________ December 22, 2003

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