MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER

K032231 · Medx Electronics, Inc. · ILY · Oct 3, 2003 · Physical Medicine

Device Facts

• Record ID: K032231
• Device Name: MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER
• Applicant: Medx Electronics, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Oct 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedX 1100 Console and MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories are an infrared lamp system, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis. The MedX LCS 100 Portable Laser (785 nm) is an infrared lamp, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

Device Story

System comprises MedX 1100 Console, LCT 100/Duolight 100/500 accessories, and MedX LCS 100 Portable Laser; utilizes 785 nm GaAlAs infrared laser diodes to emit energy for topical heating. Operated by clinicians in clinical settings; provides therapeutic heat to target areas. Output affects local blood circulation and muscle/joint pain relief. Benefits include temporary relief of aches, stiffness, and muscle spasms.

Clinical Evidence

No clinical research was conducted for this submittal. Bench testing only; device meets design and performance functional requirements and international/US medical electrical equipment safety standards.

Technological Characteristics

Infrared lamp system (21 CFR 890.5500); 785 nm GaAlAs (gallium-aluminum-arsenide) infrared laser diodes; console-based power supply with interchangeable accessories; meets international and US medical electrical equipment safety standards.

Indications for Use

Indicated for patients requiring topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains, and stiffness, relaxation of muscles, and relief of muscle spasms and minor pain/stiffness associated with arthritis.

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

• MedX 1000 Series Console & LED Accessories - MedX MCT 600 and MedX MCT 150 (K020017)

Submission Summary (Full Text)

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OCT - 6 2003

KO3A231

# 5. DISCUSSION OF SAFETY AND EFFECTIVENESS

## A. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

| Model No. /Names: | MedX 1100 Console and MedX LCT 100 & Duolight<br>100 & 500 Accessories<br>MedX LCS 100 Portable Laser |
|--------------------|-------------------------------------------------------------------------------------------------------|
| Classification: | Lamp Infrared, Heating Category ILY<br>Physical Medicine Device, 21 CFR 890.5500 (Class II) |
| Predicate Devices: | K020017<br>MedX 1000 Series Console & LED Accessories - MedX<br>MCT 600 and MedX MCT 150 |
| Contact Person: | Phil Passy<br>President and CEO<br>MedX Health Inc.<br>905 826-0766 |

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### Description of the Device

The MedX 1100 Console powers three different accessories the MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories. All therapeutic heating accessories are indication for use within the heating category, ILY, as applied for in this submission. The low level laser accessories use 785 nm GaAlAs (galliumaluminum-arsenide) infrared lasers diodes indicated for use where heat is indicated for topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis.

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#### Technological Characteristics Summary

The technological characteristics are based on the predicate device – K020017.

#### Discussion of Non-Clinical and Clinical Data

No research was conducted for this specific 510(k) submittal.

#### Conclusions Demonstrating Safety, Effectiveness and Performance

The testing carried out for the MedX 1100 Console and infra red heating accessories and the MedX LCS 100 Portable Laser indicates that they meet design and performance functional requirements. The proposed device meets the requirements of international and US medical electrical equipment standards for safety, and key performance and safety requirements.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 6 2003

Ms. Anita Saltmarche Vice President Clinical and Scientific Affairs MedX Electronics, Inc. 3535 Laird Road, Unit 2 Mississauga, Ontario Canada L5L 5Y7

Re: K032231

Trade/Device Name: MedX 1100 Console & MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories MedX LCS 100 Portable Laser (785 nm) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: July 17, 2003 Received: July 31, 2003

Dear Ms. Saltmarche:

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. Drue, 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. Iisting 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 mav 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. Anita Saltmarche

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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K032231 510 (k) Number: MedX 1100 Console & MedX LCT 100 (785 nm) and Device Names: Duolight 100 (785 nm) & 500 Accessories MedX LCS 100 Portable Laser (785 nm)

## INDICATION FOR USE

#### Indication for Use

The MedX 1100 Console and MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories are an infrared lamp system, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

The MedX LCS 100 Portable Laser (785 nm) is an infrared lamp, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-the-counter Use_ (Optional Format 1-2-96)

(Division Sign-off) Division of General Restorative Devices 510(k) Number: K032231

Miriam C. Provost

and Neurological Devic

510(k) Number K63223/