EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001

K051631 · Stargate International, Inc. · NHN · Jul 27, 2005 · Physical Medicine

Device Facts

• Record ID: K051631
• Device Name: EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001
• Applicant: Stargate International, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Jul 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Excalibur IV Light Therapy System is a non-heating lamp, infrared as described under th provisions of 21 CFR §890.5500 and is clinically indicated for: - -- Adjunctive use in providing temporary relief of minor chronic neck and shoulder pair of musculoskeletal origin. As with the predicate device, pain therapy treatment can be prescribed for pain associated with with the clinical presentation specified above by having the beams pulsed or continuous with time consid erations. The Excalibur IV Light Therapy System's variables conform to the performance specification of the clinical parameters used by the predicate devices in frequency, wavelength, time, and power outpul

Device Story

Hand-held, non-invasive pain therapy system; utilizes four laser diodes in single applicator head. Emits visible photonic energy to human tissue; operates at 635nm wavelength; Class IIIa laser; output power ≤4.5mW per non-convergent beam. Battery-operated control unit; permanently attached applicator. Used in clinical settings; operated by healthcare professionals. Provides pulsed or continuous light therapy; parameters (frequency, wavelength, time, power) adjustable. Intended to provide temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin; benefits patients through non-heating, adjunctive pain management.

Clinical Evidence

Bench testing only. Includes functional performance, electrical safety, and component specification testing. Compliance with FCC 47CFR Part 15B, UL standards for electrical components, and 21CFR Part 1040 for Class IIIa lasers.

Technological Characteristics

Gallium Aluminum Arsenide (GaAlAs) laser diodes; non-convergent beam output; 635nm (±1%) wavelength; ≤4.5mW output power per beam. Hand-held, battery-operated unit. Class IIIa laser. Complies with 21CFR Part 1040, FCC 47CFR Part 15B, and UL electrical standards. No software.

Indications for Use

Indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

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

• Quantum System (K032816)

Submission Summary (Full Text)

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JUL 2 7 2005

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# 510(k) Summary

(as required per 21CFR; §807.92)

# Excalibur IV Light Therapy System

| I. Applicant | Stargate International, Inc. |
|--------------|------------------------------|
| | 10235 South Progress Way #7 |
| | Parker, CO 80134 |
| | Phone: [phone] |
| | Fax: [phone] |

| II. Contact Name: | Robert H. Walker; CEO<br>[e-mail] |
|-------------------|------------------------------------------------------------|
|-------------------|------------------------------------------------------------|

## III. Device Name

| Proprietary Name | Excalibur IV Light Therapy System |
|----------------------|-----------------------------------|
| Common/Usual Name(s) | Low Level Laser Therapy (LLLT) |
| | Therapeutic Light System |
| Classification Name | Infrared Lamp; (21CFR; §890.5500) |
| Product Code | NHN |

# IV. Predicate Device/Substantial Equivalency

The Excalibur IV Light Therapy System is substantially equivalent to other pulsed low level therapeutic lasers and light therapy systems currently in commercial distribution. The Excalibur IV Light Therapy System has the same intended use and similar technological characteristics to predicate devices. It combines the clinically accepted therapeutic uses of previously FDA 510(k) approved light theracy. systems currently in commercial distribution into one compact and cost-effective system.

The technological equivalence to the predicate devices is substantiated by the wavelength and power output generated by the one Excalibur IV System applicator head permanently attached to the basic unit. The Excalibur IV System will provide the same treatment benefits and regimens for clinical presentations already approved by the Food and Drug Administration for the predicate devices.

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K051631 2 of 3

The predicate device the Excalibur IV System establishes equivalence to is the following:

| Predicate Device | 510(k) # | Manufacturer |
|---------------------------------------------------|----------|------------------------|
| Quantum System .................................. | K032816 | Stargate International |

#### V. Intended Use of the Device

The Excalibur IV Light Therapy System is a non-heating lamp, infrared as described under th provisions of 21 CFR §890.5500 and is clinically indicated for:

- -- Adjunctive use in providing temporary relief of minor chronic neck and shoulder pair of musculoskeletal origin.
As with the predicate device, pain therapy treatment can be prescribed for pain associated with with the clinical presentation specified above by having the beams pulsed or continuous with time consid erations. The Excalibur IV Light Therapy System's variables conform to the performance specification of the clinical parameters used by the predicate devices in frequency, wavelength, time, and power outpul

### VI. Description of the Device

The Excalibur IV Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of four laser diodes in one applicator head. It combines the clini cally accepted therapeutic treatment of numerous predicate light therapy systems currently in commercia distribution and 510(k) approved.

The system consists of a basic hand-held, battery operated control unit and a permanently attacher applicator head. The laser operates at a measured wavelength of 635nm (±1%) and complies with al performance, labeling, and manufacturing standards set forth in 21CFR Part 1040. Stargate International Inc. is a registered laser manufacturer with the Food and Drug Administration.

The laser applicator head produces an output power of ≤4.5mw2 measured, per non-convergen beam and is classified as a Class IIIa laser.

# VII. Summary of Technical Characteristics of the Device To Referenced Predicate Devices

The Excalibur IV Light Therapy System and the aforementioned predicate devices use Gallium Aluminum Arsenide (GaAlAs) diodes with non-convergent beam output to emit visible photonic energy to human tissue. The technology is dependent on the laws of physics in that the variables are free wency wavelength, power output, and time.

The performance parameters and intended use of the Excalibur IV Light Therapy System are identical to all predicate devices.

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## VIII. System Testing

The testing of the Excalibur IV Light Therapy System includes functional performance, electrica safety, and component specification. This includes four-staged manufacturing esticularly, esticulu verification.

There is no software incorporated into the operation of the Excalibur IV Light Therapy System.

The Excalibur IV Light Therapy System is manufactured, performs, is labeled, and is tested to comply with the following standards:

- FCC Standard 47CFR Part 15B .
- All Electrical Components Utilized Are UL® Approved .
- . Class IIIa Laser - 21CFR Part 1040.

#### IX. Conclusions

In accordance with testing and comparison to the predicate devices, and pursuant to 21CFR; §890.500, the Excalibur IV Light Therapy System has the same intended use, with similar functional and performance characteristics.

The device meets or exceeds the design, testing, and labeling standards required by law. The Excalibur IV Light Therapy System is manufactured and performs as intended and does not raise any new regulatory, safety, and/or clinical efficacy issues.

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Image /page/3/Picture/1 description: The image shows a black and white logo. The logo is circular in shape and features an abstract image of an eagle in the center. The eagle is composed of three curved lines that suggest the shape of the bird's head, body, and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 2005

Mr. Robert H. Walker Chief Executive Officer Stargate International, Inc. 10235 South Progress Way, #7 Parker, Colorado 80134

Re: K051631

Trade/Device Name: Excalibur IV Light Therapy System Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, non-heating for adjunctive use in pain therapy Regulatory Class: II Product Code: NHN Dated: June 15, 2005 Received: June 20, 2005

Dear Mr. Walker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaused 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 encreations to toges and the Medical Device Amendments, or to conninered province to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug. de vices martie 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 r ou may, merers, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device to such additional controls. Existing major regulations affecting your device can may oc subject to sublications, 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 1 toase be determination that your device complies with other requirements of the Act that 1127 has made a and regulations administered by other Federal agencies. You must or any I each statutes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fat 607); adoming (21 CFR Part 820); and if applicable, the electronic form in the quant) 35 real provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Robert H. Walker

This letter will allow you to begin marketing your device as described in your Section 510(k) Fins lotter will and my your e FDA finding of substantial equivalence of your device to a legally premarked predicated 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 If you acono 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 other general 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.himl.

Sincerely yours,

Stypk Curles
Mark N. Mellecker

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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# Indications For Use

| 510(k) Number (if known): | K05/63 |
|---------------------------|--------|
|---------------------------|--------|

Device Name: Excalibur IV Light Therapy System

The Excalibur IV Light Therapy System is a non-heating lamp, infrared as Indications For Use: described under the provisions of 21 CFR §890.5500 and is indicated for:

> Adjunctive use in providing temporary relief of minor chroni‹ neck and shoulder pain of musculoskeletal origin.

| <b>Prescription Use</b> | ✓ |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Division of General, Restorative and No rological Devices

**510(k) Number** K051631
Page 10 - Excalibur IV 510(k) dated June 15, 2005