LASER SYS*STIM 540, MODEL ME 540

K043586 · Mettler Electronics Corp. · ILY · May 6, 2005 · Physical Medicine

Device Facts

• Record ID: K043586
• Device Name: LASER SYS*STIM 540, MODEL ME 540
• Applicant: Mettler Electronics Corp.
• Product Code: ILY · Physical Medicine
• Decision Date: May 6, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Laser Sys*Stim, Model ME 540, 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 muscles.

Device Story

Laser Sys*Stim 540 is a portable, AC/battery-operated infrared lamp for low-level laser therapy (LLLT). System comprises a drive unit/power supply with electronics, controls, and displays, plus optional treatment probes containing visible and infrared radiating elements. Device emits infrared energy to elevate tissue temperature. Used in clinical settings by healthcare providers to treat minor muscle/joint pain, stiffness, arthritis, and muscle spasms. Output is topical heat; clinical benefit is temporary pain relief, increased local circulation, and muscle relaxation.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices. Production and quality control performance and safety testing are performed to ensure compliance with applicable safety standards for low-level laser therapy systems.

Technological Characteristics

Portable infrared lamp; AC/battery-powered. Uses visible and infrared laser diodes for topical heating. System includes drive unit/power supply and optional treatment probes. Regulated under 21 CFR 890.5500 (Product Code ILY).

Indications for Use

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

• MedX 1100 Console (K032231)
• Dynatronics' Solaris D890 Therapy Probe (K040729)
• Dynatronics' Solaris D880 Infrared Probe (K031329)

Submission Summary (Full Text)

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MAY - 6 2005

# LASER SYS*STIM® 540 MODEL ME 540 510(K) SUMMARY STATEMENT [K(TBD)]

043586

Mettler Electronics Corp. Submitter's Name: 1333 South Claudina Street Address: Anaheim, CA 92805 800-854-9305 or 714-533-2221 x314 Telephone: [phone] Fax: Rob Fleming, Regulatory Compliance Manager Contact: and Official Correspondent [e-mail] Email:

December 22, 2004 Date Prepared:

#### Device Name:

- a. TRADE NAME:
- b. CLASSIFICATION NAME:
- c. COMMON NAME:

Laser Sys*Stim 540, Model ME 540 Infrared Lamp Low Level Laser Therapy (LLLT)

#### Predicate Devices:

In our opinion, the Laser Sys*Stim® 540, Model ME 540, is substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. These predicate devices include the MedX 1100 Console (K032231), Dynatronics' Solaris D890 Therapy Probe (K040729) and Dynatronics' Solaris D880 Infrared Probe (K031329).

### Description of Device:

The Laser Sys*Stim 540, Model ME 540, is a portable, AC and battery operated non-invasive, low level infrared lamp that provides continuous and pulsed heat therapy at a fixed frequency. The system consists of a drive unit/power supply that houses the electronics, controls and displays and optional treatment probes that contain the visible and infrared radiating elements.

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# LASER SYS*STIM® 540 MODEL ME 540 510(K) SUMMARY STATEMENT [K(TBD)]

#### Device Intended Use Statement:

510(k) Number: TBD

Device Name: Laser Sys*Stim, Model ME 540

Indication for use: The Laser Sys*Stim, Model ME 540, 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 muscles.

### Comparison of Technological Characteristics Between ME 540 and Predicate Devices:

The Laser Sys*Stim, Model ME 540, and predicate devices listed above, are infrared lamps as defined in 21 CFR 890.5500 using infrared and visible laser diodes that generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.

#### Testing:

Production and quality control performance and safety testing shall be performed on each system pursuant to compliance with all applicable safety standards and regulations for low level laser therapy systems.

### Conclusion:

The Laser Sys*Stim, Model ME 540, is substantially equivalent to, and shares the same indications for use, general technical characteristics and user interface controls as, the listed predicate devices. It is designed to provide topical heating in the infrared and visible wavelength spectrum at energy levels previously found acceptable by the Food and Drug Administration. Each unit shall undergo compliance verification testing prior to introduction into interstate commerce to insure conformance to specifications and applicable safety standards.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features the department's name encircling a symbol. The symbol consists of four stylized, abstract shapes that resemble human figures or birds in flight. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 6 2005

Mr. Robert E. Fleming Regulatory Compliance Manager Mettler Electronics Corporation 1333 South Claudina Street Anaheim, California 92805

Re: K043586

Trade/Device Name: Laser Sys*Stim 540, Model ME 540 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: March 9, 2005 Received: March 10, 2005

Dear Mr. Fleming:

We have reviewed your Section 510(k) premarket notification of intent to market the device w Chave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to Connieres that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercrore, market the Act include requirements for annual registration, listing of general controls providering 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oous of concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Drivice complies with other requirements of the Act that I DA has made a actering administered by other Federal agencies. You must of ally I cuclar statutes and regalances ancluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, 01); good manufacturing practice requirements as set CFR art 6077, laboring (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Robert E. Fleming

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to oegin maine of substantial equivalence of your device to a legally premarket notification: "The PDF 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 If you desire specific advice for your do november 10 . Also, please note the regulation entitled, Condor the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain Misolanding of Icrerchee to premainsvilibilities under the Act from the Division of Small other general Information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Laser Sys*Stim 540, Model ME 540

Indications for Use:

The Laser Sys*Stim 540, Model ME 540 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 muscles.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

tive

043586