The BioFlex™ LD-175& LD-1200 Treatment Heads are intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.

Device Description

The BioFlex™ LD-175 & LD-1200 Treatment Heads are designed to be used only part of the BioFlex Professional System. This system was cleared in K023621. This system provides a low level Dior tex I royessional bysied displays the treatment sessions. As such, this device is a Class II device, having Regulation Number: 21 CFR part 890.5500. Product Code ILY.

The BioFlex™ LD-175 & LD-1200 Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, drug-free, and low cost benefit to the patient, the practitioner and the health care system.

This device is different from other predicate devices in that it is part of a regiment that uses proprietary, interchangeable treatment heads to allow various protocols (and software loaded in a P.C. computer to download protocols) and record session / patient data.

AI/ML Overview

This document is a 510(k) summary for the BioFlex™ LD-175 & LD-1200 Treatment Heads and does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document primarily focuses on:

Device Description and Intended Use: The BioFlex™ LD-175 & LD-1200 Treatment Heads are Class II Low Level Laser treatment heads that apply energy in the infrared spectrum for topical heating for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of muscle tissue. It is a prescription-only device.
Substantial Equivalence: The manufacturer, Meditech International Inc., asserts that these treatment heads are substantially equivalent to three predicate devices: K 033768 (Altus Medical, Inc.), K031612 (Avicenna Laser Technology, Inc.), and K024179 (Palomar Medical Products).
Quality System and Calibration: It states that the device "has benefited from design, development, testing and production procedures that conform to Quality Systems" and that "A series of factory calibration tests are conducted to verify the device is accurate and calibrated (and can maintain calibration over its useful life)."
Safety and Effectiveness: A general statement is made that the device "is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy."

The document does not include:

A table of acceptance criteria and reported device performance.
Details about a specific study (sample size, data provenance, ground truth establishment, etc.) that demonstrates the device meets pre-defined acceptance criteria for safety or effectiveness.
Information on expert involvement, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based on the provided text. The document acts as a submission for regulatory clearance based on substantial equivalence to existing devices, rather than a detailed report of a performance study against specific acceptance criteria.

Summary

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K 04/885

Exhibit 19 Summary of Safety & Effectiveness

FEB 2 4 2005

25 June 2004

This summary is submitted in behalf of: Meditech International Inc. 411 Horner Ave., Unit #1, Etobicoke, Ontario, Canada M8W 4W3 Voice phone number-416 251 1055 Fax phone number- 416 251-2446

This summary is submitted by: Richard Keen Compliance Consultants 1151 Hope Street Stamford, Connecticut, 06907 voice phone number (203) 329 2700) fax phone number (203) 329 2345.

The scientific concept on which this device is based is the principle that by stimulating a local area with low level laser to relieve pain.

The intended use of this device is for a trained health care professional to diagnose that specific patients would benefit from this therapy and treat patients for specific ailments using specific protocols.

The "Indications for Use" for this device is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.

This is a prescription only device. The labeling, instructions and user operations are designed for health care professionals.

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Kouiji

Exhibit 19

Summary of Safety & Effectiveness

Meditech International Inc. has determined that the BioFlex™ LD-175 & LD-1200 Treatment Heads are substantially equivalent to the performance of three predicate devices:

. K 033768, Optional Infrared Handpiece for CoolGlide Lasers, manufactured by Altus Medical, Inc.
K031612, Lamp, Infrared, Alt Laser, Model Vtr 75 manufactured by Avicenna Laser . Technology, Inc.
K024179, Lamp Infrared, Palomar Lightcube, manufactured by Palomar Medical Products, .

A series of factory calibration tests are conducted to verify the device is accurate and calibrated (and can maintain calibration over its useful life). The BioFlex™ LD-175 Treatment Head has benefited from design, development, testing and production procedures that conform to Quality Systems.

This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. Meditech International Inc. continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

CERTIFICATION:

I hereby certify this Summary of Safety and Effectiveness applies for the above indicated device.

Dr. Fred Kahn President Meditech International Inc. 411 Horner Ave., Unit #1, Etobicoke, Ontario, Canada M8W 4W3 Voice 416 251 1055 Fax 416 251-2446

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and head, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2005

Meditech International, Inc. c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, Connecticut 06907

Re: K041885

Trade/Device Name: BioFlex™ LD-175 & LD-1200 Treatment Heads Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: IL Y Dated: November 28, 2004 Received: December 2, 2004

Dear Mr. Keen:

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 10 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. Richard Keen

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

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 (If known): K 041885

Device Name: BioFlex™ LD-175& LD-1200 Treatment Heads

Indication For Use:

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

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 (ODE)

Sheet 1 of 1

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
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.(b)
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.