MAESTRO MDTL LASER SYSTEM

K053473 · Advanced Medical Technologies, Inc. · ILY · Feb 3, 2006 · Physical Medicine

Device Facts

• Record ID: K053473
• Device Name: MAESTRO MDTL LASER SYSTEM
• Applicant: Advanced Medical Technologies, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrums 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

Maestro MDTL Laser System is a non-invasive, portable therapeutic device; delivers light energy via visible red and infrared laser diodes to target tissue. System consists of a base control unit and interchangeable laser probes connected by cable. Control unit houses electronics/circuits to power probes; probes house laser diodes. Device operates via AC power. Used in clinical settings to provide topical heating; elevates tissue temperature to relieve minor muscle/joint pain, stiffness, arthritis pain, or muscle spasms; increases local blood circulation; promotes muscle relaxation. Healthcare providers operate the system to deliver therapy; output is thermal energy applied to patient tissue. Benefits include temporary pain relief and improved circulation.

Clinical Evidence

No clinical data. Evidence consists of functional performance testing and electrical safety testing to demonstrate compliance with international standards (ISO 9000:2000, EN46001, Directive 89/336).

Technological Characteristics

Infrared lamp (21 CFR 890.5500). Utilizes infrared and visible laser diodes. AC-powered base unit with external laser probes. Complies with ISO 9000:2000, EN46001, and electromagnetic compatibility Directive 89/336. Designed to comply with 21 CFR 1010 and 1040 performance standards.

Indications for Use

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

• Super Nova and Acubeam Systems (K001179)
• MLT-1000 IR Laser System (K033986)
• BioFlex Professional Therapy System (K023621)
• Thor International DDII Laser System (K033923)
• Chattanooga Group Vectra Genisys Laser System (K040662)

Submission Summary (Full Text)

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FEB 3 1005

Laser Therapeutics, Inc Maestro MDTL Laser System 510(k) Notification December 12, 2005

# APPENDIX B

K053473

## SUMMARY OF SAFETY AND EFFICACY

## Maestro MDTL Therapeutic Laser System (as per 21 CFR Part 807.92)

#### I. GENERAL INFORMATION

| Device Generic Name: | Infrared Lamp |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Maestro MDTL Laser System |
| Device Classification: | Class II, Performance Standards<br>21CFR Part 890.5500 - Infrared Lamp, |
| Product Code: | ILY |
| Applicant Name and Address: | Advanced Medical Technologies, Inc.<br>101 Waterside Drive<br>Centerville, MA 02632<br>508 / 790-9300<br>Neil Camera, President<br>[e-mail] |

#### II. DEVICE DESCRIPTION

The Maestro MDTL Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by AC power and can be used with a variety of laser probes.

The Maestro MDTL Laser System is comprised of a Base Unit and select Laser Probes. The Control Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Control Unit by a cable, which plugs into the rear of the Control Unit. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.

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#### III. INDICATIONS FOR USE

The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrums 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 Maestro MDTL Laser System is substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. Representative predicate devices to the Maestro MDTL Laser System include, but are not limited to, the Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986), the Meditech International Inc BioFlex Professional Therapy System (K023621), the Thor International DDII Laser System (K033923) and the Chattanooga Group Vectra Genisys Laser System (K040662).

### V. Summary of the Technical Characteristics of the Maestro MDTL Laser System as Related to the Referenced Predicate Devices.

The Maestro MDTL 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 joint pain. The Maestro System and the named predicate devices have the same intended uses and similar technical and performance characteristics.

#### VI. Testing

Testing of the System includes functional performance testing and electrical safety testing. The Maestro MDTL Laser System is manufactured to comply with the following international standards:

ISO 9000:2000 EN46001 Directive 89/336 regarding electromagnetic compatibility

#### VII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the Maestro MDTL Laser has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with applicable performance standards promulgated by Federal Food and Drug Administration, such as 21 CFR 1010 and 1040. The Maestro MDTL Laser System performs as intended and do not raise any new safety or efficacy issues.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2006

Advanced Medical Technologies, Inc. c/o Ms. M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services, Inc. 12101-A Cullen Blvd. Houston, Texas 77047-2951

Re: K053473

Trade/Device Name: Maestro MDTL Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: December 12, 2005 Received: December 14, 2005

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. 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 vou 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" (21 CFR 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/industry/support/index.html.

Sincerely vours.

Barbare Ruelin
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Mark N. Melkerson Acting 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

### Indications for Use

510(k) Number (if known):

Pending K 653473

Device Name:

### Maestro MDTL Laser System

## Indications for Use:

The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and ioint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODDE)

Barbare method for MXM

Division of General, Restorative, and Neurological Devices

510(k) Number: K053473 18