QUASAR, MODEL MD21

K032379 · Quantum Skincare, Inc. · ILY · Nov 20, 2003 · Physical Medicine

Device Facts

• Record ID: K032379
• Device Name: QUASAR, MODEL MD21
• Applicant: Quantum Skincare, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quasar MD21 infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

Device Story

Quasar MD21 is a handheld infrared heat lamp; utilizes infrared and red LEDs packaged in a compact plastic head. Device emits pulsed infrared energy to elevate tissue temperature; red LEDs provide visual operation indicator. Operated by user; requires 25-minute warm-up period. Applied directly to skin or held just above skin surface. Provides temporary relief of minor muscle/joint pain, stiffness, arthritis pain, and muscle spasms; promotes muscle relaxation and increased local blood circulation. Benefits patient through non-invasive thermal therapy.

Clinical Evidence

Bench testing only. Functional performance and electrical safety testing were conducted to verify device operation and safety compared to predicate devices.

Technological Characteristics

Handheld infrared lamp; utilizes infrared and red LEDs for energy emission. Compact plastic housing. Operates via pulsed light in the infrared spectrum. No complex software or connectivity described.

Indications for Use

Indicated for individuals experiencing minor muscle and joint pain, stiffness, minor arthritis pain, or muscle spasms requiring temporary relief via topical heating and increased local blood circulation.

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

• Mu Photonics Pain Therapist (K012598)
• Biolight PCD

Submission Summary (Full Text)

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K032379 (pg 1 of 2)

510(k) Submission, Infrared Lamp, 21 CFR 890.5500 Quantum Skincare, Inc., Ringgold, LA 71068

# Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Quasar MD21 Infrared Heat Lamp.

#### Company making the submission:

| Name: | This summary is submitted in behalf of:<br><b>Quantum Skincare, Inc.</b> | or | This summary is submitted by: |
|--------------------|--------------------------------------------------------------------------|----|----------------------------------------------------------------------------------|
| Address: | 3157 Military Road<br>Ringgold, LA 71068 . | | Delphi Consulting Group<br>11874 South Evelyn Circle<br>Houston, Texas 770713404 |
| Telephone:<br>Fax: | 1-318-894-9490 | | 1-713-723-4080<br>1-775-429-9524 |
| Contact: | Jim Cobb<br>President | | J. Harvey Knauss<br>Consultant |
| E-mail: | [e-mail] | | [e-mail] |

#### 1. Device Name:

・

| Trade/Proprietary Name: | Quasar MD21 Infrared Heat Lamp. |
|-------------------------|---------------------------------|
| Common/Usual Name: | Infrared heat lamp. |
| Classification Name: | Infrared lamp 21 CFR § 890.5500 |

## 2. Predicate Device:

The Quasar MD21 Infrared Heat Lamp is substantially equivalent to other infrared lamps on the market, such as the Mu Photonics Pain Therapist, K012598 manufactured by Nu Photonics, Inc., and Biolight PCD,

## 3. Intended use of the Device:

The Quasar MD21 infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

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## 4. Description of the Device:

The Quasar MD21 consists of a collection of both infrared and red diodes [LEDs], packaged in a compact plastic head. The system emits pulsed light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. For operation turn on LEDs for a time period of twenty-five (25) minutes prior to use.

#### 5. Summary of the technological characteristics of the device Compared to predicate devices:

The Quasar MD21 and the above referenced predicate devices are infrared lamps as defined in 21 CFR § 890.5500. These devices utilize infrared diodes [LEDs], to provide topical heating for the temporary relied of muscle and/or joint pain. The temperatures achieved by these devices are the same, using a similar number of diodes {LEDs], over a similar coverage area. The devices are handheld, and intended to be placed directly on the skin or held just over the skin to provide the heating.

## 6. Testing:

Testing of the Quasar MD21 included functional performance testing and electrical safety testing.

## 7. Conclusions:

Based upon the testing and comparison to the predicate devices, the Quasar MD21 has the same intended uses, with similar technological characteristics. The system performs as intended and raises no new safety or effectiveness issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.

Public Health Service

NOV 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ouantum Skincare, Inc. c/o Mr. J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071-3404

Re: K032379

Trade/Device Name: Quasar MD21, Infrared Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 9, 2003 Received: October 14, 2003

Dear Mr. Knauss:

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. J. Harvey Knauss

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] on [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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510(k) Number KO32379

#### Quasar MD21, Infrared Lamp Device Name:

## Indications for use:

The Quasar MD21 infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

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

Prescription Use X

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Muriam C. Provost

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

510(k) Number K032379