(89 days)
Not Found
No
The document describes a therapeutic heat lamp system that uses laser light for topical heating. There is no mention of AI or ML in the device description, intended use, or performance studies. The device appears to be a standard medical device for heat therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to provide "temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm," and "temporary increase in local blood circulation; and/or the temporary relaxation of muscle," which are all therapeutic effects. The "Device Description" also explicitly calls it a "therapeutic heat lamp."
No
The device is described as a therapeutic heat lamp system intended for temporary relief of mild muscle and joint pain, and increased blood circulation, not for diagnosing medical conditions.
No
The device description explicitly details hardware components including a control console, treatment handpiece probe, connecting cable, laser diode sources, optical fibers, and a protective lens. It also mentions functional performance testing and electrical safety testing related to these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the skin surface for therapeutic purposes (pain relief, increased blood circulation, muscle relaxation). This involves direct interaction with the patient's body for treatment.
- Device Description: The description details a therapeutic heat lamp system that emits light energy to the skin. It describes the hardware components and how the energy is delivered to the patient's skin.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the collection or analysis of any biological specimens.
The device is a therapeutic device that applies energy to the body for treatment, which is distinct from the function of an IVD.
N/A
Intended Use / Indications for Use
The LUMIX ULTRA IR Lamp Systems are intended to emit energy in the visible and 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, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
Product codes
ILY
Device Description
The LUMIX ULTRA IR Lamp Systems are intended for use as therapeutic heat lamps. The Systems are non-invasive devices that emit light energy to the skin-surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature.
The LUMIX ULTRA IR Lamp Systems deliver visible and invisible laser light beams at wavelengths between 650 and 1064 nm using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic red laser quide light with 3 mW of power. The Systems consist of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable.
The control consoles are made of standard medical PVC material and are designed to be placed on a desktop or table in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display.
The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probes contain a protective lens at the aperture, which is made of glass suitable for medical applications.
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
Not Found
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
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Summary of Performance Studies
Testing of the LUMIX ULTRA Systems includes functional performance testing and electrical safety testing. The Systems are manufactured to comply with the following international standards:
IEC 60601-1:2006 - Ed. 3 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60825-1:2014 - Ed. 2 Safety of Laser Products - Part 1: Classification of laser devices and requirements
IEC 60601-1-2:2010 - Ed. 3 Medical Electrical Equipment - Part 1-2: Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6:2013 - Ed. 3.1 Medical Electrical Equipment - Part 1-6: Collateral Standard: Usability
IEC 60601-2-22:2012 - Ed. 3.1 Medical Electrical Equipment - Part 2-22: Particular requirements for basic and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 63204:2006 Software for Medical Devices: Software life cycle processes
ISO 14971:2012 – Ed. 2 Risk Management to Medical Devices
Key Metrics
Not Found
Predicate Device(s)
K132016, K101893, K123971, K120604
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
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
July 26, 2016
USA Laser Biotech Inc. % Joyce M. Heinrich President Texas Applied Biomedical Services, Inc. 1201 Cullen Boulevard. #A Houston, Texas 77047
Re: K161198
Trade/Device Name: Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: April 28, 2016 Received: April 28, 2016
Dear Ms. Heinrich:
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
1
Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
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" (21 CFR 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 Post-market 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,
Christopher J. Ronk -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161198
Device Name
LUMIX ULTRA 1 IR Lamp System; LUMIX ULTRA 2 IR Lamp System; LUMIX ULTRA 3 IR Lamp System
Indications for Use (Describe)
The LUMIX ULTRA IR Lamp Systems are intended to emit energy in the visible and 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, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
. GENERAL INFORMATION Device Generic Name:
Infrared Therapeutic Heat Lamp
Trade Name:
LUMIX ULTRA 1 IR Lamp System LUMIX ULTRA 2 IR Lamp System LUMIX ULTRA 3 IR Lamp System
| Device Classification: | Class II, Performance Standards |
|---|---|
| 21CFR Part 890.5500 – Infrared Lamp |
Product Code: ILY
Applicant Name and Address:
USA Laser Biotech Inc. 9210 Forest Hill Avenue Richmond, VA 23235 USA Telephone: 877 / 423-6169
510(k) Number: K161198
II. Device Description
The LUMIX ULTRA IR Lamp Systems are intended for use as therapeutic heat lamps. The Systems are non-invasive devices that emit light energy to the skin-surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature.
The LUMIX ULTRA IR Lamp Systems deliver visible and invisible laser light beams at wavelengths between 650 and 1064 nm using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic red laser quide light with 3 mW of power. The Systems consist of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable.
The control consoles are made of standard medical PVC material and are designed to be placed on a desktop or table in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display.
The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probes contain a protective lens at the aperture, which is made of glass suitable for medical applications.
4
III. Indications For Use
The LUMIX ULTRA IR Lamp Systems are intended to emit energy in the visible and 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,
minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
IV. Predicate Devices
The LUMIX ULTRA IR Lamp Systems are substantially equivalent to other therapeutic heat lamps that are currently in commercial distribution. These predicate devices include, but are not limited to:
-
- USA Laser Biotech Inc. LUMIX 3 Series Infrared Heat Lamp Therapy Systems (K132016),
-
- USA Laser Biotech Inc. NEXUS Series IR Heat Lamp Systems (K101893),
-
- CYNOSURE 1064nm Diode Laser (K123971), and
-
- ELTECH s.r.l. K-Laser Cube 1, K-Laser Cube 2, K-Laser Cube 3, K-Laser Cube 4 (K120604).
V. Summary of the Technical Characteristics of the LUMIX ULTRA System as Related to the Referenced Predicate Devices
The LUMIX ULTRA IR Lamp Systems and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.
VI. Testing
Testing of the LUMIX ULTRA Systems includes functional performance testing and electrical safety testing. The Systems are manufactured to comply with the following international standards:
5
| IEC 60601-1:2006 - Ed. 3 | Medical Electrical Equipment, Part 1:
General Requirements for Basic Safety
and Essential Performance |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60825-1:2014 - Ed. 2 | Safety of Laser Products - Part 1:
Classification of laser devices and
requirements |
| IEC 60601-1-2:2010 - Ed. 3 | Medical Electrical Equipment - Part 1-2:
Collateral Standard: Electromagnetic
disturbances - Requirements and tests |
| IEC 60601-1-6:2013 - Ed. 3.1 | Medical Electrical Equipment - Part 1-6:
Collateral Standard: Usability |
| IEC 60601-2-22:2012 - Ed. 3.1 | Medical Electrical Equipment - Part 2-22:
Particular requirements for basic and
essential performance of surgical,
cosmetic, therapeutic and diagnostic laser
equipment |
| IEC 63204:2006 | Software for Medical Devices: Software
life cycle processes |
| ISO 14971:2012 – Ed. 2 | Risk Management to Medical Devices |
VII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the LUMIX ULTRA IR Lamp Systems have the same intended uses, with similar functional and performance characteristics. TThe LUMIX ULTRA IR Lamp Systems are designed to comply with applicable performance standards promulgated by the U.S. Food and Drug Administration. These Systems perform as intended and do not raise any new safety or efficacy issues.