Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3

K161198 · Usa Laser Biotech, Inc. · ILY · Jul 26, 2016 · Physical Medicine

Device Facts

• Record ID: K161198
• Device Name: Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3
• Applicant: Usa Laser Biotech, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LUMIX ULTRA IR Lamp Systems are intended to emit energy in the visible and 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, or muscle spasm, the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

Device Story

LUMIX ULTRA 1, 2, and 3 are therapeutic infrared lamp systems; deliver visible and invisible laser light (650-1064 nm) via gallium arsenide (GaAs) diodes; energy transmitted through quartz optical fibers to handpiece probe; non-therapeutic red laser guide light (3 mW) assists targeting; system comprises control console (membrane interface, LCD) and handpiece probe; used in clinical settings by healthcare providers; provides topical heating to elevate tissue temperature; benefits include temporary pain relief, increased circulation, and muscle relaxation.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety), IEC 60825-1 (laser safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-2-22 (laser performance), and ISO 14971 (risk management).

Technological Characteristics

Infrared lamp system; GaAs diode laser sources (650-1064 nm); quartz fiberoptic delivery; medical-grade PVC console and probe housing; glass protective lens; desktop form factor; pressure-activated membrane interface with LCD; compliant with IEC 60601-1, IEC 60825-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, and IEC 62304.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain, stiffness, minor arthritis pain, muscle spasm, increased local blood circulation, or 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

• LUMIX 3 Series Infrared Heat Lamp Therapy Systems (K132016)
• NEXUS Series IR Heat Lamp Systems (K101893)
• CYNOSURE 1064nm Diode Laser (K123971)
• K-Laser Cube 1, K-Laser Cube 2, K-Laser Cube 3, K-Laser Cube 4 (K120604)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 26, 2016

USA Laser Biotech Inc. % Joyce M. Heinrich President Texas Applied Biomedical Services, Inc. 1201 Cullen Boulevard. #A Houston, Texas 77047

Re: K161198

Trade/Device Name: Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: April 28, 2016 Received: April 28, 2016

Dear Ms. Heinrich:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Post-market Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Christopher J. Ronk -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K161198

Device Name

LUMIX ULTRA 1 IR Lamp System; LUMIX ULTRA 2 IR Lamp System; LUMIX ULTRA 3 IR Lamp System

Indications for Use (Describe)

The LUMIX ULTRA IR Lamp Systems are intended to emit energy in the visible and 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, or muscle spasm, the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

Type of Use (Select one or both, as applicable)

| <div><span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|-------------------------------------------------------------------------------------------------|
| <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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#### . GENERAL INFORMATION Device Generic Name:

Infrared Therapeutic Heat Lamp

### Trade Name:

LUMIX ULTRA 1 IR Lamp System LUMIX ULTRA 2 IR Lamp System LUMIX ULTRA 3 IR Lamp System

| Device Classification: | Class II, Performance Standards |
|------------------------|-------------------------------------|
| | 21CFR Part 890.5500 – Infrared Lamp |

Product Code: ILY

Applicant Name and Address:

USA Laser Biotech Inc. 9210 Forest Hill Avenue Richmond, VA 23235 USA Telephone: 877 / 423-6169

### 510(k) Number: K161198

### II. Device Description

The LUMIX ULTRA IR Lamp Systems are intended for use as therapeutic heat lamps. The Systems are non-invasive devices that emit light energy to the skin-surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature.

The LUMIX ULTRA IR Lamp Systems deliver visible and invisible laser light beams at wavelengths between 650 and 1064 nm using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic red laser quide light with 3 mW of power. The Systems consist of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable.

The control consoles are made of standard medical PVC material and are designed to be placed on a desktop or table in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display.

The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probes contain a protective lens at the aperture, which is made of glass suitable for medical applications.

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#### III. Indications For Use

The LUMIX ULTRA IR Lamp Systems are intended to emit energy in the visible and 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, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

#### IV. Predicate Devices

The LUMIX ULTRA IR Lamp Systems are substantially equivalent to other therapeutic heat lamps that are currently in commercial distribution. These predicate devices include, but are not limited to:

- 1. USA Laser Biotech Inc. LUMIX 3 Series Infrared Heat Lamp Therapy Systems (K132016),
- 2. USA Laser Biotech Inc. NEXUS Series IR Heat Lamp Systems (K101893),
- 3. CYNOSURE 1064nm Diode Laser (K123971), and
- 4. ELTECH s.r.l. K-Laser Cube 1, K-Laser Cube 2, K-Laser Cube 3, K-Laser Cube 4 (K120604).

#### V. Summary of the Technical Characteristics of the LUMIX ULTRA System as Related to the Referenced Predicate Devices

The LUMIX ULTRA IR Lamp Systems and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.

#### VI. Testing

Testing of the LUMIX ULTRA Systems includes functional performance testing and electrical safety testing. The Systems are manufactured to comply with the following international standards:

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| IEC 60601-1:2006 - Ed. 3 | Medical Electrical Equipment, Part 1:<br>General Requirements for Basic Safety<br>and Essential Performance |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60825-1:2014 - Ed. 2 | Safety of Laser Products - Part 1:<br>Classification of laser devices and<br>requirements |
| IEC 60601-1-2:2010 - Ed. 3 | Medical Electrical Equipment - Part 1-2:<br>Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests |
| IEC 60601-1-6:2013 - Ed. 3.1 | Medical Electrical Equipment - Part 1-6:<br>Collateral Standard: Usability |
| IEC 60601-2-22:2012 - Ed. 3.1 | Medical Electrical Equipment - Part 2-22:<br>Particular requirements for basic and<br>essential performance of surgical,<br>cosmetic, therapeutic and diagnostic laser<br>equipment |
| IEC 63204:2006 | Software for Medical Devices: Software<br>life cycle processes |
| ISO 14971:2012 – Ed. 2 | Risk Management to Medical Devices |

#### VII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the LUMIX ULTRA IR Lamp Systems have the same intended uses, with similar functional and performance characteristics. TThe LUMIX ULTRA IR Lamp Systems are designed to comply with applicable performance standards promulgated by the U.S. Food and Drug Administration. These Systems perform as intended and do not raise any new safety or efficacy issues.