LEP2000 THERAPY SYSTEM

K073689 · International Medical Instruments, Inc. · NHN · Nov 13, 2008 · Physical Medicine

Device Facts

• Record ID: K073689
• Device Name: LEP2000 THERAPY SYSTEM
• Applicant: International Medical Instruments, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Nov 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LEP2000 Photonic Therapy System is a device that emits energy in the infrared spectrum and is indicated for adjunctive use in providing temporary relief joint pain.

Device Story

LEP 2000 Photonic Therapy System is an infrared lamp device. It emits energy in the infrared spectrum to provide temporary relief of joint pain. Used as an adjunctive therapy. Operated by healthcare professionals in a clinical setting. The device applies infrared energy to the affected area to produce therapeutic effects. Benefits include temporary pain relief for joints.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infrared lamp device; emits energy in the infrared spectrum. Class II device under 21 CFR 890.5500. Product code NHN.

Indications for Use

Indicated for adjunctive use in providing temporary relief of joint pain in patients requiring such therapy.

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.

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2008

International Medical Instruments, Inc. % Texas Applied Biomedical Services Ms. M. Joyce Heinrich 12101-A Cullen Boulevard Houston, Texas 77047-2951

Rc: K073689

Trade/Device Name: LEP 2000 Photonic Therapy System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: NHN Dated: October 23, 2008 Received: October 28, 2008

Dear Ms. Heinrich:

We have reviewed your Section 510(k) promarket 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 (sec 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 - Ms. M. Joyce Heinrich

'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. Millman

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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## ATTACHMENT II

## Indications for Use Statement

510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________

Device Name: LEP 2000 Photonic Therapy System

Indications for Use:

The LEP2000 Photonic Therapy System is a device that emits energy in the infrared spectrum and is indicated for adjunctive use in providing temporary relief joint pain.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × OR

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

Over-the -counter-use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODDE)

Dail R. P. Ogle firmin
(Division Sign-off)

idn-off ) Division of General Restorative, and Neurological Devices (DGRND)

510(k) Number_________________________________________________________________________________________________________________________________________________________________ K073689

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