The MediLaser is an infrared lamp that is 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, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.

Device Description

The MediLaser is a portable, hand held. AC operated non-invasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MediLaser System, structured as requested:

Acceptance Criteria and Study for the MediLaser System (K063745)

The provided document is a 510(k) Premarket Notification Summary for the MediLaser System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical study results against specific acceptance criteria for performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Functional Performance	Produce topical heating for the purpose of elevating tissue temperature.	Device emits energy in the infrared spectrum to provide topical heating, consistent with predicate devices.
Therapeutic Effect	Implicit: Achieve temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, temporary increase in local circulation, and muscle relaxation.	The device performs as intended for its stated indications for use, which are congruent with predicate devices. It is designed to comply with generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the FDA.
Electrical Safety	Meet relevant electrical safety standards.	Electrical safety testing was conducted. (No specific standards or results are detailed in this summary).
Software Functionality	No software required for operation.	No software is required to operate the device.
Safety and Efficacy	Not raise any new safety or efficacy issues compared to predicate devices.	The MediLaser performs as intended and does not raise any new safety or efficacy issues.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical test set with a specific sample size. The testing mentioned (functional performance and electrical safety) likely refers to bench testing and engineering verification, not human subject studies. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of a clinical test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. The submission is a 510(k) for an infrared lamp, demonstrating substantial equivalence to legally marketed predicate devices. It does not involve a clinical study with a ground truth established by medical experts for a diagnostic or treatment outcome. The "ground truth" here is the established performance characteristics and safety profile of the predicate devices in the infrared lamp category.

4. Adjudication Method for the Test Set

This information is not applicable, as there was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic imaging devices to compare the performance of human readers with and without AI assistance. The MediLaser is a therapeutic device (infrared lamp), and the submission focuses on substantial equivalence based on physical characteristics and intended use.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This information is not applicable as the device is a hardware-based therapeutic infrared lamp, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is based on the established safety and effectiveness of legally marketed predicate devices (e.g., Thor IR Lamp System/ Super Nova/ Acubeam systems) and compliance with generally accepted therapeutic heat performance specifications. The device's performance aligns with the expected output and effects of these predicate infrared lamps, which have a long history of safe use for the stated indications.

8. The Sample Size for the Training Set

No training set for an algorithm was used or described, as this device does not involve AI or machine learning.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there was no training set for an algorithm.

Summary

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K063745

Appendix A

APR 2 3 2007

4/300/ສິງຕິວັ

510 (k) Premarket Notification Summary (Per 21 CFR 807.92)

MediLaser System

I. Applicant	Laser Thera, LLC
	Shelly Henry, President
	11108 Ashford Drive
	Yukon OK 73099
II. Device Name:
Proprietary Name:	MediLaser
Common/Usual Name:	Infrared lamp
Classification Name:	Infrared lamp (21 CFR 890.555)
Product Code	ILY

The MediLaser System is substantially equivalent to other infrared lamps III. currently in commercial distribution such as the Thor IR Lamp System/ Super Nova/ Acubeam systems.

IV. Intended use of the Device

The MediLaser is 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, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.

V. Description of Device

The MediLaser is a portable, hand held. AC operated non-invasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency.

VI. Summary of the technical characteristics of the MediLaser The MediLaser and the aforementioned predicate devices are an infrared lamp as defined in 21 CFR 890.5500. These devices utilize infrared diodes to generate topical heating for the purpose of elevating tissue temperatures for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local circulation and the temporary relaxation of muscle. The systems are intended to be placed directly on the skin to provide heating.

VII. Testing

Testing of the MediLaser included functional performance testing and electrical safety testing.

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VIII Software Verification and Validation - No software is required to operate the device.

IX Conclusions

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

The MediLaser performs as intended and do not raise any new safety or efficacy issues.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laser Thera, LLC % Ms. Shelly Henry 5300 N. Meridian, Suite 1 Oklahoma City, Oklahoma 73112

APR 2 3 2007

Re: K063745

Trade/Device Name: MediLaser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: March 9, 2007 Received: March 9, 2007

Dear Ms. Henry:

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 - Ms. Shelly Henry

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Molkerson

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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Indications for Use

510(k) Number (if known):

Device Name:

MediLaser

Indications For Use:

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

510(k) Number K062398

Prescriptions Use × (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

N/A