EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001

K041530 · Stargate International, Inc. · NHN · Oct 14, 2004 · Physical Medicine

Device Facts

• Record ID: K041530
• Device Name: EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001
• Applicant: Stargate International, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Oct 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Excalibur Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is clinically indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Device Story

Hand-held, battery-operated, non-invasive pain therapy system; utilizes two laser diodes in one applicator head. Emits visible photonic energy to human tissue; operates at 635nm wavelength; Class IIIa laser; output power ≤4.5mw per non-convergent beam. Used in clinical settings; operated by healthcare professionals. Provides adjunctive treatment for minor chronic neck and shoulder pain of musculoskeletal origin. Beams can be pulsed or continuous; treatment parameters (frequency, wavelength, time, power) align with predicate devices. Benefits include temporary pain relief.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included functional performance, electrical safety, and component verification across four manufacturing stages.

Technological Characteristics

Hand-held, battery-operated unit with permanently attached applicator head. Uses Gallium Aluminum Arsenide (GaAlAs) diodes; non-convergent beam output. Wavelength: 635nm (±1%). Power output: ≤4.5mw per beam. Class IIIa laser. Complies with 21 CFR Part 1040, 47CFR Part 15B (FCC), 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

• Tuco Erchonia PL3000 (K012580)
• Quantum System (K032816)

Submission Summary (Full Text)

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K041530 1/3

# 510(k) Summary

(as required por 21CFR; §807.92)

## Excalibur Light Therapy System

OCT 1 4 2004

| 1. 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 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 Light Therapy System is substantially equivalent to other pulsed low level therapeutic lasers and light therapy systems currently in commercial distribution. The Excalibur Light Therapy System has the same intended use and similar tochnological characteristics to predicate devices. It combines the clinically accepted therapcutic uses of previously FDA 510(k) approved light therapy systems currently in commercial distribution into onc 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 System applicator head permanently attached to the basic unit. The Excalibur System will provide the same treatment benefits and regimens for clinical presentations already cleared by the Food and Drug Administration for the predicate devices.

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The predicate devices the Excalibur System establishes equivalence to include the following:

| Predicate Device | 510(k) # | Manufacturer |
|------------------------------------------------|----------|------------------------|
| Tuco Erchonia PL3000 ......................... | K012580 | Tuco Innovations |
| Quantum System ......................... | K032816 | Stargate International |

#### V. Intended Use of the Device

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

- Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain i 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 considerations. The Excalibur Light Therapy System's variables conform to the performance specifications of the clinical parameters used by the predicate devices in frequency, wavelength, time, and power output.

#### VI. Description of the Device

The Excalibur Light Therapy System is a band-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of two laser diodes in one applicator head. It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution and 510(k) cleared.

The system consists of a basic hand-held, battery operated control unit and a permanently attached applicator head. The laser operates at a measured wavelength of 635mm (±1%) and complies with all 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-convergent beam and is classified as a Class IIIa laser.

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

The Excalibur 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 frequency, wavolongth, power output, and time.

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

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### VIII. System Testing

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

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

The Excalibur 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 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 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

OCT 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041530

Trade/Device Name: Excalibur 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: September 3, 2004 Received: September 7, 2004

Dear Mr. Walker:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your became in ad 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 conniner by provision 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 r ou may, incress, while 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 rr your device 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. Robert H. Walker

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mailioning of substantial equivalence of your device to a legally premarket notification: The PDF mailing of cation 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 240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Compremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities 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/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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### Indications For Use

K041530 510(k) Number (if known):

Device Name: Excalibur Light Therapy System

The Excalibur 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 chronic neck and shoulder pain of musculoskeletal origin.

Prescription Use (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)

Muriam C. Provost

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

**510(k) Number** K041530

Page 10 - Excalibur 510(k) dated June 4, 2004