EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X

K083560 · Lighthouse Technical Innovations, Inc. · ILY · Dec 11, 2008 · Physical Medicine

Device Facts

• Record ID: K083560
• Device Name: EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
• Applicant: Lighthouse Technical Innovations, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Dec 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Expanded Spectrum Photo Therapy Device (ESPT-3X) 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, . - muscle spasm, 0 - the temporary increase in local blood circulation and/or . - promoting relaxation of muscle. . The ESPT-3X is for prescription use only.

Device Story

ESPT-3X is a non-invasive, portable, Class IV therapeutic laser console; delivers infrared energy to target tissue via handpiece. Includes 1 mW red aiming beam for visualization; operator-controlled manual timer. Used in clinical settings by healthcare providers to elevate tissue temperature; intended to reduce musculoskeletal pain, relieve stiffness/spasms, and increase local circulation. Benefits patient through non-invasive thermal therapy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Class IV therapeutic laser; infrared spectrum emission; console-based with handpiece accessory; 1 mW red aiming beam; manual timer; non-invasive; portable form factor.

Indications for Use

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

• Alt Laser, Model VTR 75 (K031612)
• K-Laser 6d-zh (K050070)
• K-Laser Desktop 6d (K050070)

Submission Summary (Full Text)

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K 083560

#### 510(k) Summary (per 21 CFR 807.92(c))

#### 1. Applicant

Lighthouse Technical Innovations, Inc. 701 Northlake Blvd., Suite 101 North Palm Beach, FL 33408

DEC 1 1 2008

Contact Person: Eugene Barnett, Vice President Tel: [phone] Fax: [phone] e-mail: [e-mail]

Date Prepared: July 1, 2008

#### 2. Device Name

Trade Name: Expanded Spectrum Photo Therapy Device (ESPT-3X) Common/ Usual Name: Infrared Lamp Classification Name: Lamp, Infrared, Therapeutic Heating Regulation Number: 890.5500 Product Code: ILY Classification: II Panel: Physical Medicine

#### 3. Predicate Devices

The ESPT-3X is equivalent to the following devices:

| Device | 510(k)<br>Number | Manufacturer |
|-------------------------|------------------|---------------------------------|
| Alt Laser, Model VTR 75 | K031612 | Avicenna Laser Technology, Inc. |
| K-Laser 6d-zh | K050070 | Eltech, S.R.L. |
| K-Laser Desktop 6d | K050070 | Eltech, S.R.L. |

#### 4. Intended Use

The Expanded Spectrum Photo Therapy Device (ESPT-3X) 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, .
- muscle spasm, 0

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- the temporary increase in local blood circulation and/or .
- promoting relaxation of muscle. .

The ESPT-3X is for prescription use only.

#### 5. Description of the Device

The ESPT-3X console is a non-invasive, portable, therapeutic medical laser designed to deliver high level (Class IV) energy/power for the purpose of reducing musculoskeletal pain. A "hand piece" accessory evenly delivers a Class IV laser to the target tissue. This channel is equipped with a red aiming beam (1 mW) that provides visible illumination of the area being treated. The console is equipped with a separate and independent timer that is manually set by the operator.

### 6. Technical Characteristics and Substantial Equivalence

The ESPT-3X provides Class IV therapy for reducing musculoskeletal pain and has the same technological characteristics (e.g., wavelength, power, and frequency) as other commercially available Class IV devices. In addition, the ESPT-3X was tested extensively to ensure conformance to applicable standards and FDA regulations. In summary, the ESPT-3X is substantially equivalent to the predicate devices listed in this 510(k) submission such that they share the same Indications for Use and technological characteristics.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a seal.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lighthouse Technical Innovations, Inc. % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 E. Aurora Road, Unit B7 Twinsburg, Ohio 44087

DEC 1 1 2008

Re: K083560

Trade/Device Name: The Expanded Spectrum Photo Therapy Device (ESPT-3X) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: December 1, 2008 Received: December 2, 2008

Dear Mr. Lehtonen:

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 - Mr. Daniel W. Lehtonen

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 yours.

Mark M. Millman

Mark N. Melkerson 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): K 083560

### Device Name: The Expanded Spectrum Photo Therapy Device (ESPT-3X)

Indications for Use:

The Expanded Spectrum Photo Therapy Device (ESPT-3X) 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,
- muscle spasm,
- the temporary increase in local blood circulation and/or .
- promoting relaxation of muscle.

Prescription Use X (Part 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 OF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Ned Kroid Forman

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

**510(k) Number** K083560