QUANTUM LIGHT THERAPY SYSTEM

K032816 · Stargate International, Inc. · NHN · Mar 26, 2004 · Physical Medicine

Device Facts

• Record ID: K032816
• Device Name: QUANTUM LIGHT THERAPY SYSTEM
• Applicant: Stargate International, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quantum Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for: - A- Adjunctive use in providing temporary relief of minor chronic neck and shoulder paint of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.

Device Story

Quantum Light Therapy System is a hand-held, battery-operated, non-invasive pain therapy device. It utilizes interchangeable applicator heads containing laser diodes and light-emitting diodes (LEDs) to deliver non-heating, visible photonic energy to tissue. The system is operated by a clinician to provide therapeutic light treatment. The device transforms electrical power into specific wavelengths of light (609-645nm range) to provide temporary relief of minor chronic musculoskeletal pain. The system is compact and portable. Clinical benefit is derived from the application of light therapy to the affected area, consistent with established therapeutic regimens for similar light therapy systems. The device is intended for adjunctive use in pain management.

Clinical Evidence

Bench testing only. The device underwent functional performance, software, firmware, electrical safety, and component specification testing conducted by an independent laboratory. Compliance with standards including FCC 47CFR Part 15B, IEC 60825-1, IEC 60601-2-22, and IEC 60601-1-2 was verified.

Technological Characteristics

Hand-held, battery-operated control unit with interchangeable applicator heads. Emits light via laser diodes and LEDs. Wavelengths: 609-645nm. Laser output: <5mW (Class IIIa). LED output: non-coherent diffuse light. Standards: FCC 47CFR Part 15B, UL approved components, 21CFR Part 1040 (Class IIIa laser), IEC 60825-1, IEC 60601-2-22, IEC 60601-1-2.

Indications for Use

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

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)
• Super Nova; Accubeam (K001179)
• MedX 100 Series (K020017)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "Stargate" in bold, black letters. Above the word is a thin, black oval shape. To the right of the oval is a black star shape.

MAR 2 6 2004

# Final 510(k) Summary For Application #K032816 Dated March 23, 2004

(as required per 21CFR; §807.92)

Quantum Light Therapy System

The following modified 510k summary is in response to the issues indicated by the Food and Drug Administration in a phone conversation on March 22, 2004. This represents Stargate's Final Amended Summary.

| I. Applicant | Stargate International, Inc. |
|-------------------|------------------------------|
| | 10235 South Progress Way #7 |
| | Parker, CO 80134 |
| | Phone: [phone] |
| | Fax: [phone] |
| II. Contact Name: | Robert H. Walker; CEO |

III. Device Name

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

[e-mail]

### IV. Predicate Device/Substantial Equivalency

The Quantum Light Therapy System is substantially equivalent to other pulsed low level therapeutic lasers and light therapy systems currently in commercial distribution. The Quantum 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 therapy systems currently in commercial distribution into one complete, compact, and cost-effective system.

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The technological equivalence to the predicate devices is substantiated by the wavelengths and power outputs generated by the individual Quantum System applicator heads. Depending on the applicator head chosen by the clinician, the Quantum System will provide the same treatment benefits and regimens for conditions already approved by the Food and Drug Administration.

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

| Predicate Device | 510(k) # | Manufacturer |
|----------------------|----------|---------------------------|
| Tuco Erchonia PL3000 | K012580 | Tuco Innovations |
| Super Nova; Accubeam | K001179 | Light Force Therapy, Inc. |
| MedX 100 Series | K020017 | MedX Electronics, Inc. |

### V. Intended Use of the Device

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

- A- Adjunctive use in providing temporary relief of minor chronic neck and shoulder paint of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.
### VI. Description of the Device

The Quantum Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of both laser and light emitting diodes(LED) in three optional applicator heads. It combines the clinically accepted therapentic treatment of numerous predicate light therapy callor itsacs: It commercial distribution and 510(k) approved into one complete, compact, and costeffective system.

The system consists of a basic hand-held, battery operated control unit and three optional (one-LED; two-laser) and interchangeable applicator heads which can only be used with the Quantum Light Therapy System control unit.

The three distinct applicator heads produce wavelengths that range between 609-645mm which falls within the spectrum as defined by 21 CFR §890.5500.

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The two laser applicator heads produce an output power of <Smw prom-convergent beam and I he two laser apprication neads produced wavelength of 635mm 11% and ontinued of themse are classified as Class IIIa lastis. Bour operate and included on tortly in 21CFR Part 1040. Stargeton tional, Inc. has filed as a registered laser manufacturer with the Food and Drug Administration.

The distinct LED applicator head produces a non coherent diffuse light source. This applicator head operates at a measured wavelength of 628mm ±3%.

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

The Quantum Light Therapy System and the aforementioned predicate devices use diodes to emit I he Qualium Light Included in the intended use of the Quantum Light Therapy System is visible photomic energy to numal ussue. The Stargate applicator head chosen by the clinician.

### VIII. System Testing

The testing of the Quantum Light Therapy System includes functional performance, software, firmware, electrical safety, and component specification. This includes four-staged manufactiffinate, electrical salety, and component specifications by an outside independent laboratory.

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

- FCC Standard 47CFR Part 15B せ
- All Electrical Components Utilized Are UL® Approved ◆
- Class IIIa Laser 21CFR Part 1040. .
- IEC60825-1, Amendment 2 해
- IEC 60601-2-22 ャ
- EMC: IEC 60601-1-2 .

#### IX. Conclusions

In accordance with testing and comparison to the predicate devices, and pursuant to 21CFR; 5890.500, the Quantum Light Therapy System has the same intended uses, with similar functional and performance characteristics.

The device meets or excceds the design, testing, and labeling standards required by law. The Quantum 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 the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

Public Health Service

MAR 2 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032816

Trade/Device Name: Quantum 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: December 23, 2003 Received: December 29, 2003

Dear Mr. Walker:

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. Robert H. Walker

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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# Indications For Use

### 510(k) Number (if known): K032816

Device Name: Quantum Light Therapy System

The Quantum Light Therapy System is a non-heating lamp, infrared as described Indications For Use: 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 using the QS-2; QS-4; and/or the QS-L applicator heads.

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)

Miriam C. Provost

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

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**510(k) Number** K132816