ML830TP

K080786 · Microlight Corporation of America · ILY · Oct 3, 2008 · Physical Medicine

Device Facts

• Record ID: K080786
• Device Name: ML830TP
• Applicant: Microlight Corporation of America
• Product Code: ILY · Physical Medicine
• Decision Date: Oct 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ML830 TP is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscles.

Device Story

ML830 TP is a non-invasive, hand-held therapeutic device; utilizes battery-powered electronics to activate a single infrared/laser diode; delivers energy in visible and near-infrared spectrum to skin surface; provides topical heating to elevate tissue temperature; used for temporary relief of minor muscle/joint pain, stiffness, arthritis pain, muscle spasm, and to increase local blood circulation and relax muscles; operated by placing probe on or near skin surface; no clinical data provided; device is not sterile; contact surface cleaned with 70% isopropyl alcohol.

Clinical Evidence

No clinical data. Bench testing only, including functional performance and electrical safety testing.

Technological Characteristics

Hand-held probe; battery-powered; single infrared/laser diode; non-heating lamp (21 CFR 890.5500); non-invasive; non-sterile; surface cleanable with 70% isopropyl alcohol.

Indications for Use

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

• Powerlaser by Powermedic APS (K070516)
• PowerLaser 90 (K030692)
• Thor VR Single Diode Laser Treatment Probe (K070024)

Submission Summary (Full Text)

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# APPENDIX D

OCT - 3 2008

## SUMMARY OF SAFETY AND EFFICACY

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

# ML830ºTP - PRELIMINARY STATEMENT

ML830 TP

#### I. Applicant:

MicroLight Corporation of America 2935 Highland Lakes Drive Missouri City, Texas 77459

Contact Person: Fred A. Simpson, Esq. c/o Jackson Walker L.L.P. 713-752-4248 telephone -713-752-4221 facsimile e-mail fsimpson(@jw.com

Date Prepared: March 18, 2008

### II. Device Name

Proprietary Name: Common / Usual Name: Classification Name: Product Code:

Infrared Lamp Infrared Lamp (21 CFR 890.550) ILY

#### III. Predicate Device

The ML830®TP is substantially equivalent to other single diode infrared lamps currently in commercial distribution such as the Powerlaser by Powermedic APS which is the subject of a clearance letter from the Agency under 510(k) number K070516, which itself was predicated on the PowerLaser 90, the subject of K030692. In addition, or in the alternative, the ML830®TP is substantially equivalent to the Thor VR Single Diode Laser Treatment Probe which is the subject of a clearance letter from the Agency under 510(k) K070024..

These three predicate devices were cleared by the Agency for introduction into interstate commerce by means of the FDA's 510(k) notification process.

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K080786

R.

### IV. Intended Use of the Device

The ML830 TP is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscles.

### V. Description of the Device

The ML830 TP is a non-invasive, easy to use hand-held therapeutic device consisting of a probe containing battery-powered electronics that activate a single diode which delivers infrared energy. The probe is intended to be placed on or near the surface of the skin to provide temporary relief from pain.

### Summary of the technical characteristics of the ML830® TPto the referenced VI. predicate devices.

The ML830®TP and the aforementioned predicate devices are non-heating lamps, as defined in 21 CFR 890.5500. These devices utilize infrared and laser diodes to generate topical hearing for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.

### VII. Testing

Testing of the ML830 TP will include functional performance testing, functional performance testing, and electrical safety testing in accordance with all applicable standards for this type of medical device.

# VIII. Sterility - Packaging Description

The ML830 TP is not intended to be sterilized, but the contact surface may be cleaned with a cloth moistened with 70% isopropal alcohol. The devise is delivered in a styrofoam container and metal box which may be used as a protective carrying case during the economic life of the device.

### IX. Conclusions

Pursuant to the testing and substantial comparison with the predicate devices, the ML830 TP has the same intended uses, with similar functional and performance characteristics as those predicate devices listed in Section III above. The ML830 TP is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature as reported in literature and accepted by the U.S. Food & Drug Administration.

The ML830®TP is manufactured and performs as intended and does not raise any new safety or efficacy issues.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MicroLight Corporation of America c/o Fred A. Simpson, Esq. Jackson Walker L.L.P. 1401 McKinney Street, Suite 1900 Houston, Texas 77010

OCT - 3 2008

Rc: K080786

Trade/Device Name: ML830® TP Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY September 30, 2008 Received: October 1, 2008

Dear Mr. Simpson:

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. Iisting 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 - Fred A. Simpson, Esq.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark N. Milkerson

Mark N. Melkerson 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

# STATEMENT OF INDICATIONS FOR USE

510(k) Number:

K080786

Device Name:

# ML830®TP

Indications for Use. MicroLight Corporation of America's ML830®TP is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscles.

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

(Division Sign-Off)

OR

Over the Counter Use: (Optional Format 1-2-96)

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

**510(k) Number** k080876

ML830®TP 510(k) Premarket Notification - K080786 March 18, 2008, as re-amended August 29, 2008

510(k) Number K080786