LUMINA 1600, 3300 AND 6600 SYSTEMS

K052814 · Usa Laser Biotech, Inc. · ILY · Nov 30, 2005 · Physical Medicine

Device Facts

• Record ID: K052814
• Device Name: LUMINA 1600, 3300 AND 6600 SYSTEMS
• Applicant: Usa Laser Biotech, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Nov 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LUMINA Systems are intended to emit energy in the 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 promoting relaxation of muscle.

Device Story

LUMINA 1600, 3300, and 6600 Systems are non-invasive therapeutic devices providing continuous infrared heat therapy. System consists of a console housing electronics/controls and treatment probe applicators. Device emits infrared energy to target tissue areas to elevate temperature. Used for temporary relief of minor muscle/joint pain, stiffness, arthritis pain, muscle spasm, increased local blood circulation, and muscle relaxation. Operation involves clinician-directed application of probes to target areas. Output is thermal energy; healthcare providers use this to manage musculoskeletal symptoms. Benefits include non-pharmacological pain relief and improved local circulation.

Clinical Evidence

Bench testing only. Functional performance and electrical safety testing conducted in accordance with applicable standards for infrared lamp medical devices. No clinical trial data presented.

Technological Characteristics

Infrared lamp (21 CFR 890.5500). Utilizes infrared and visible laser diodes for energy emission. System architecture includes a console for electronics/controls and treatment probe applicators. Non-invasive, continuous heat therapy delivery.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, or muscle spasm; temporary increase in local blood circulation; and temporary 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

• Avicenna Laser Therapy, Inc. ALT Laser Model VTR 75 (K031612)
• Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179)
• Meditech International, Inc. BioFlex Professional Therapy System (K023621)

Submission Summary (Full Text)

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052814 1 of 2

2005

# APPENDIX B

### 510(k) PREMARKET NOTIFICATION SUMMARY (per 21 CFR 807.92)

## LUMINA Infrared Heat Lamp Therapy Systems Models 1600, 3300 and 6600

#### I. Applicant:

USA Laser Biotech Inc. 10115 Merrimac Road Richmond, VA 23235 Telephone: [phone]

Key Contact: Nelson Marquina. PhD

#### II. Device Name

Proprietary Name: LUMINA 1600, 3300 and 6600 Systems Common / Usual Name: Infrared Lamp Classification Name: Infrared Lamp (21 CFR 890.5500) Product Code: ILY

#### III. Intended Use of the Device

The LUMINA Systems are intended to emit energy in the 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 promoting relaxation of muscle.

#### IV. Predicate Devices

The LUMINA Systems are substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. These predicate devices include, but are not limited to, the Avicenna Laser Therapy, Inc. ALT Laser Model VTR 75 (K031612), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), and Meditech International, Inc. BioFlex Professional Therapy System (K023621).

#### V. Description of the Device

The LUMINA 1600, 3300 and 6600 Systems are easy to use, non-invasive therapeutic device that provides continuous heat therapy. The Systems consist of a Console that houses the electronics and controls and a treatment probe applicators that deliver the infrared energy to the target area.

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K052814

### Summary of the technical characteristics of the LUMINA Infrared Heat Lamp VI. Therapy Systems the referenced predicate devices

The LUMINA 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.

#### VII. Testing

Testing of the LUMINA Systems include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device.

### VIII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the LUMINA Systems have the same intended uses, with similar functional and performance characteristics. The Systems are designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2005

USA Laser Biotech, Inc. c/o M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services 12101- A Cullen Boulevard Houston, Texas 77047-2951

Re: K052814

Trade/Device Name: Lumina 1600 System, Lumina 3300 and 6600 Systems Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: November 5, 2005 Received: November 9, 2005

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.

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- M. Joyce Heinrich

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally premation on "Nesults in "Needassification 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 dosire 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/industry/support/index.html.

Sincerely yours,
Barbara Buchm

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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### APPENDIX C

### Indications for Use

510(k) Number (if known):

Pending K052814

Device Name: Lumina 1600 System Lumina 3300 and 6600 Systems

### Indications for Use:

The LUMINA Systems, as listed above, are intended to emit energy in the 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.

X Prescription Use: (Part 21 CFR 801 Subpart D) 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 (ODDE)

AND/OR

Barbore Buellmp

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neral. Restorative and Neurological Devices

510(k) Number K052614