(273 days)
Not Found
No
The document describes a standard infrared therapeutic laser with adjustable power and a handpiece. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device description or intended use.
Yes
The device description explicitly states, "Gallieon-1 is a non-invasive, low energy infrared therapeutic medical laser."
No.
The device's intended use is to provide topical heating for the temporary relief of pain, stiffness, muscle spasm, and to increase local blood circulation, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a "low energy infrared therapeutic medical laser" and is "composed of adjustable output powers, handpiece (emitter) for the delivery of light, on/off button". This indicates it is a hardware device that emits energy, not a software-only device.
Based on the provided information, the Gallieon-1 system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as providing topical heating for therapeutic purposes related to muscle and joint pain, stiffness, spasms, and blood circulation. This is a direct therapeutic application on the body.
- Device Description: The description confirms it's a non-invasive therapeutic medical laser that emits infrared energy for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. IVDs are used to analyze biological samples.
Therefore, the Gallieon-1 system falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
ILY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care centers, physical therapy laboratories, and family practices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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. |
1
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
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.
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.
2
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
3
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
4
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)
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.
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)
5
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."