The Gallieon-1 system 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
. relief of minor pain and stiffness associated with arthritis
relief of muscle spasm ●
the temporary increase in local blood circulation
. promoting relaxation of muscle/ligament

The Gallieon -1 SYSTEM is for prescription use only.

The device is indicated for emitting energy in the infrared spectrum to provide topical heating tissue temperature for temporary relief of minor muscle spasm, pain and stiffhess associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

Device Description

Gallieon-1 is a non-invasive, low energy infrared therapeutic medical laser that is intended to perform laser therapy in the health care centers, physical therapy laboratories, and family practices. It is composed of adjustable output powers, handpiece (emitter) for the delivery of light, on/off button to activate and deactivate the infrared emission. Also Gallieon-1 meets FDA requirement of the skin temperature test and the electromagnetic compatibility and electrical safety test.

AI/ML Overview

The provided FDA 510(k) summary for the Gallieon-1 device does not include detailed information on acceptance criteria or a specific study proving the device meets performance criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technical characteristics, and safety standards, rather than providing a performance study with detailed acceptance criteria.

However, based on the available information, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Safety	Conformance to applicable standards and FDA regulations (CFR 1040 part 820)	"The Gallieon-1 was tested extensively to ensure conformance to applicable standards and FDA regulations." "The Gallieon-1 meets the applicable requirement of CFR 1040 part 820, under design/change control, and verified/validated to applicable standards/guidance documents." Also mentions meeting "FDA requirement of the skin temperature test and the electromagnetic compatibility and electrical safety test."
Performance	To provide topical heating for the intended uses (temporary relief of minor muscle and joint pain/stiffness, relief of minor pain and stiffness associated with arthritis, relief of muscle spasm, temporary increase in local blood circulation, promoting relaxation of muscle/ligament).	"Gallieon-1 is a non-invasive, low energy infrared therapeutic medical laser that is intended to perform laser therapy..." "Gallieon-1 generates infrared therapy for treatment of selected medical conditions and shares the same or similar basic characteristics and the same intended use as the predicate device." No specific quantitative performance metrics like temperature achieved, pain reduction scores, or circulation increase percentages are provided.
Technical Characteristics	Generation of infrared therapy, adjustable output powers, handpiece (emitter), on/off button.	"It is composed of adjustable output powers, handpiece (emitter) for the delivery of light, on/off button to activate and deactivate the infrared emission." "Gallieon-1 generates infrared therapy for treatment of selected medical conditions..."
Substantial Equivalence	Similar intended use, basic characteristics, and technology to predicate devices (K031612, K050070, K083560).	"Gallieon-1 generates infrared therapy for treatment of selected medical conditions and shares the same or similar basic characteristics and the same intended use as the predicate device." "Therefore, the proposed Gallieon-1 is substantially equivalent to Altlaser, Model VTR 75, cleared under K031612; to Klaser therapy probe, cleared under K050070; to ESPT (Expanded Spectrum Photo Therapy Device)-3X, cleared under K083560."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical study or performance test involving a specific "test set" in the context of assessing device efficacy or accuracy against ground truth. The evaluation is primarily focused on demonstrating safety through adherence to standards and substantial equivalence to existing devices. Therefore, these details are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no specific "test set" for performance evaluation is described, information regarding experts for ground truth establishment is not applicable and not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no dedicated test set for performance evaluation is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

The Gallieon-1 is an infrared lamp for therapeutic heating, not an imaging or diagnostic device that would typically involve "human readers" or "AI assistance" in the sense of image interpretation. Therefore, an MRMC comparative effectiveness study is not relevant to this device type, and no such study is mentioned.

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

The Gallieon-1 is a physical therapy device that delivers infrared energy. It does not contain an algorithm in the sense of AI or image processing that would have a "standalone" performance. Its "performance" would be related to its ability to generate heat and deliver infrared radiation within specified parameters, which is assessed through engineering and safety tests rather than an algorithm-only evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a device like the Gallieon-1, "ground truth" would primarily relate to its physical properties and safety parameters, such as:

Irradiance/Power Output: Measured by calibrated optical power meters.
Wavelength: Measured by spectrometers.
Temperature Safety: Measured by thermocouples/IR thermometers on skin models or in-vivo studies (though no direct study with results is provided, only a statement of meeting the "skin temperature test").
Electrical Safety & EMC: Determined by compliance with established electrical and electromagnetic compatibility standards, using specialized testing equipment.

The document states, "The Gallieon-1 was tested extensively to ensure conformance to applicable standards and FDA regulations," and "meets the FDA requirement of the skin temperature test and the electromagnetic compatibility and electrical safety test." This implies that the "ground truth" for safety and basic technical specifications were compliance with these established standards and validated physical measurements. There is no mention of clinical outcomes data or expert consensus on efficacy for the purpose of this 510(k) summary, as substantial equivalence is the primary pathway.

8. The sample size for the training set

Not applicable. As a physical therapeutic device, there is no "training set" in the context of machine learning or algorithmic development. Its design and manufacturing are based on established engineering principles and safety standards for infrared lamps.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this device.

Summary

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MAY 1 2 2014

K132529 Page 1 of 2

510(k) Summary (per 21 CFR 807.92)

1.Applicant

Future Device and Technology, Inc. 4322 Wilshire Blvd., Suite 303 Los Angeles, CA 90010 Contact Person: Mr. Soung Don Chung Tel:213-520-2127/323-450-2180 Fax:323-939-1499 E-mail:k.chung2008@yahoo.com

Date Prepared: July 12, 2013

2. Device Name

Proprietary/Trade Name: Gallieon-1 Common/Usual Name: Infrared Lamp Classification Name: Lamp, Infrared, therapeutic heating Regulation Number: 890.5500 Product Code: ILY Classification: II Panel: Physical Medicine

3. Predicate Devices

The Gallieon-1 is equivalent to the following devices:

510(k) number	Device	Manufacturer
K031612	ALT Laser, Model VTR 75	Avicenna Laser Technology, Inc.
K050070	Klaser Therapy Probe	Eltech, S.R.L
K083560	ESPT-3X	Light Technical Innovation, Inc.

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4. Intended Use of the device

The Gallieon-1 system 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
. relief of minor pain and stiffness associated with arthritis
relief of muscle spasm ●
the temporary increase in local blood circulation
. promoting relaxation of muscle/ligament

The Gallieon -1 SYSTEM is for prescription use only.

5. Description of the Device

6. Technical Characteristics and Substantial Equivalence

Gallieon-1 generates infrared therapy for treatment of selected medical conditions and shares the same or similar basic characteristics and the same intended use as the predicate device. Therefore, the proposed Gallieon-1 is substantially equivalent to Altlaser, Model VTR 75, cleared under K031612; to Klaser therapy probe, cleared under K050070; to ESPT (Expanded Spectrum Photo Therapy Device)-3X, cleared under K083560.

7. Safety and Effectiveness

There are no substantive differences between the product defined in this 510(k) submission and the predicate device. They are similar to the technologies that are currently used in other similar medical devices. In addition,The Gallieon-1 was tested extensively to ensure conformance to applicable standards and FDA regulations. The Gallieon-1 meets the applicable requirement of CFR 1040 part 820, under design/change control, and verified/validated to applicable standards/guidance documents.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 12, 2014

Future Device and Technology Incorporated Mr. Soung Don Chung Chief Executive Officer 4322 Wilshire Boulevard, Suite 303 Los Angeles, California 90010

Re: K132529

Trade/Device Name: Gallieon-1 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Il Product Code: ILY Dated: April 18. 2014 Received: April 22, 2014

Dear Mr. Chung:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Soung Don Chung

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K 132529

Device Name Gallieon-l

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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.