(336 days)
Not Found
No
The description focuses on the physical properties and function of a laser therapy device for topical heating, with no mention of AI or ML capabilities.
Yes
The device is described as a "laser therapy device" intended for "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," which aligns with the definition of a therapeutic device.
No
The device is intended to emit energy for therapeutic purposes (topical heating for pain relief, increased circulation, muscle relaxation), not to diagnose a condition.
No
The device description explicitly details hardware components such as laser sources, optical fibers, focusing lenses, and a flexible arm, indicating it is a physical device that emits infrared energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Intended Use: The Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are intended to emit energy to provide topical heating for the temporary relief of pain and stiffness, increased blood circulation, and muscle relaxation. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a laser therapy device that applies energy to the body's surface. It does not mention the analysis of biological specimens.
- Performance Studies: The performance studies focus on the device's ability to elevate tissue temperature, which is relevant to its therapeutic function, not its ability to analyze biological samples.
The device is a therapeutic device that applies energy to the body, not a diagnostic device that analyzes samples from the body.
N/A
Intended Use / Indications for Use
The Lumix 3 100W Plus and Lumix 3 250W Ultra Systems are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperary 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
Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are laser therapy devices for applications suitable to be used in an ambulatory setting and under the care of a licensed healthcare provider. In particular the device works by providing infrared energy to elevate tissue temperature.
The Lumix 3 series laser therapy heat lamp heat devices deliver visible and invisible laser light at the wavelength of 910 nm (pulsed infrared), 808nm (continuous and interrupted infrared) and 650nm (continuous red visible). The pulsed laser sources used are of diodic type for pulsed working mode; the continuous laser sources used are of diodic type for continuous and frequenced working mode.
The laser light beam produced by the diode is carried to the focusing lens optic fibers with very low attenuation and high mechanical strength. The laser light, produced by the different sources, is emitted in a single bright beam, which at the optical unit output has a diameter equal to at 20mm. The flexible arm can be oriented by the user at will to heat-treat the required tissue area.
The optical unit contains a focusing lens with a high transmission coefficient used to focus the light beam carried by the optical fibers on the tissue to be treated. In order to identify precisely the tissue area to be irradiated, it is important to have a guide light available (650nm red) with a beam collimated with the laser light beam. The guide light allows one to visualize the target site clearly. The red quide light has no therapeutic value.
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
ambulatory setting and under the care of a licensed healthcare provider.
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)
Bench Testing:
Electrical safety and functional performance testing were conducted on the Lumix 3 Systems demonstrating that the devices are compliant with FDA recognized consensus standards. These standards include the following international standards:
- EN 60601-1:2007 Medical Electrical Equipment, Part 1, General Requirements for Safety
- EN 60601-1-2:2007 Medical Electrical Equipment, General Requirement for Safety. Electromagnetic Compatibility
- EN 60601-2-22 Medical Electrical Equipment, Part 2, Particular Requirements for the safety of diagnostic and therapeutic laser equipment
- EN 60601-1-4:1996 Programmable electrical medical systems
- ISO 13485:2003 Medical Device Quality Management System
- Council Directive 93/42/EEC EC Declaration of Conformity
Non-Clinical Testing:
The use of light energy to generate heat for therapeutic use has been well documented and is generally accepted alternative treatment modality for the temporary relief of pain and tissue repair.
The Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are capable of achieving therapeutic heat temperature range of 40 - 45 degrees centigrade as accepted by the FDA. An increase in topical heating of the tissue level by at least 5° centigrade was reached within one (1) minute demonstrated in the clinical testing conducted. The therapeutic temperature range was maintained for at least ten (10) minutes.
The temperature versus time measurements was conducted on 8 subjects at various physical locations, i.e., leg, neck, back and shoulder. The preexposed topical skin temperature ranged from 36 to 39 degrees centigrade. These data from the Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems demonstrates that they meet the generally accepted topical temperature range for therapeutic heat of 40 - 45 degrees centigrade during the recommended treatment time of 10 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K132016 Lumix 3 Plus and Lumix 3 Ultra May 23, 2014
JUN 0 2 2014
| 510(k) Summary (as per 21 CFR 807.92) |
|---|
| --------------------------------------- |
I. GENERAL INFORMATION
| Device Generic Name: | Infrared Low Level Laser System |
|---|---|
| Trade Name: | Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems |
| Device Classification: | Class II, Performance Standards 21CFR Part 890.5500 – Infrared Lamp |
| Product Code: | ILY |
| Applicant Name and Address: | USA Laser Biotech, Inc. 9210 Forrest Hill Avenue Richmond, VA 23235 Telephone: 804 / 377-2234 |
| 510(k) Number: | K132016 |
Device Description:
Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are laser therapy devices for applications suitable to be used in an ambulatory setting and under the care of a licensed healthcare provider. In particular the device works by providing infrared energy to elevate tissue temperature.
The Lumix 3 series laser therapy heat lamp heat devices deliver visible and invisible laser light at the wavelength of 910 nm (pulsed infrared), 808nm (continuous and interrupted infrared) and 650nm (continuous red visible). The pulsed laser sources used are of diodic type for pulsed working mode; the continuous laser sources used are of diodic type for continuous and frequenced working mode.
The laser light beam produced by the diode is carried to the focusing lens optic fibers with very low attenuation and high mechanical strength. The laser light, produced by the different sources, is emitted in a single bright beam, which at the optical unit output has a diameter equal to at 20mm. The flexible arm can be oriented by the user at will to heat-treat the required tissue area.
1
K132016 Lumix 3 Plus and Lumix 3 Ultra May 23, 2014
The optical unit contains a focusing lens with a high transmission coefficient used to focus the light beam carried by the optical fibers on the tissue to be treated. In order to identify precisely the tissue area to be irradiated, it is important to have a guide light available (650nm red) with a beam collimated with the laser light beam. The guide light allows one to visualize the target site clearly. The red quide light has no therapeutic value.
Technical Observations:
The pulsed and superpulsed laser emission consists of a sequence of pulses lasting about 200 ns repeated at a pulse rate varying from 1 Hz to 100,000 Hz. (cycles per second).
The laser emission from the 808nm continuous wave diode can be in a continuous emission or a modulated (interrupted) mode. In the modulated mode the pulses are emitted at varying pulse rates from 1 Hz to 100,000 Hz (cycles per second).
By setting the modulation DUTY-CYCLE it is possible to change the lighting time as to the interruption one into the 5 seconds period:
| DUTY-
| CYCLE | TRAIN IMPULSES LENGTH | PAUSE DURATION |
|---|---|---|
| 20 | 1 second | 4 seconds |
| 50 | 2.5 seconds | 2.5 seconds |
| 80 | 4 seconds | 1 second |
The amount of energy at the optical system output point can be calculated by applying the following formula:
E(J)total = E(j)pw910nm + E(j)cw808nm
Where:
E(j)pw910nm = Peak power (W) x diodes number x impulse width (sec) x modulation x treatment time (sec)
E(i)pw910nm = Peak power (W) x Coefficient x modulation x treatment time (sec)
Where Coefficient is:
1 if the diode is on in CW modality 0.5 if the diode is on in pulsed modality
2
III. Indications for Use:
The Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are 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, 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 3 100W Plus and Lumix 3 250W Ultra are substantially equivalent to other infrared therapeutic devices that are currently in commercial distribution. Followinq is a list of the predicate devices cleared by the FDA via 510K Notification process.
| 510(k) Number | Predicate Device Name | Manufacturer |
|---|---|---|
| K042256 | ICL 60 Plus HFPL System | USA Laser Biotech, Inc. |
Summary of the Technical Characteristics of the Lumix 3 Systems V. as Related to the Referenced Predicate Devices:
The Lumix 3 100W Plus System is the same technologically and functionally as the ICL 60, Model 100 and the Lumix 3 250W Ultra is the same as the ICL 60. Model 250. These predicate devices were cleared by the 510K process (K042256). The Lumix 3 Systems have the same intended use as the ICL 60 Systems. These devices utilize infrared laser diodes, SLD diodes and visible LED diodes for the purpose of providing adjunctive use in pain therapy.
3
Bench Testing: VI.
Electrical safety and functional performance testing were conducted on the Lumix 3 Systems demonstrating that the devices are compliant with FDA recognized consensus standards. These standards include the following international standards:
| STANDARD | DESCRIPTION |
|---|---|
| EN 60601-1:2007 | Medical Electrical Equipment, Part 1, General |
| Requirements for Safety | |
| EN 60601-1-2:2007 | Medical Electrical Equipment, General Requirement |
| for Safety. Electromagnetic Compatibility | |
| EN 60601-2-22 | Medical Electrical Equipment, Part 2, Particular |
| Requirements for the safety of diagnostic and | |
| therapeutic laser equipment | |
| EN 60601-1-4:1996 | Programmable electrical medical systems |
| ISO 13485:2003 | Medical Device Quality Management System |
| Council Directive | |
| 93/42/EEC | EC Declaration of Conformity |
Non-Clinical Testing: VII.
The use of light energy to generate heat for therapeutic use has been well documented and is generally accepted alternative treatment modality for the temporary relief of pain and tissue repair.
The Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are capable of achieving therapeutic heat temperature range of 40 - 45 degrees centigrade as accepted by the FDA. An increase in topical heating of the tissue level by at least 5° centigrade was reached within one (1) minute demonstrated in the clinical testing conducted. The therapeutic temperature range was maintained for at least ten (10) minutes.
The temperature versus time measurements was conducted on 8 subjects at various physical locations, i.e., leg, neck, back and shoulder. The preexposed topical skin temperature ranged from 36 to 39 degrees centigrade. These data from the Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems demonstrates that they meet the generally accepted topical temperature range for therapeutic heat of 40 - 45 degrees centigrade during the recommended treatment time of 10 minutes.
4
K132016 Lumix 3 Plus and Lumix 3 Ultra May 23, 2014
VIII. Conclusions:
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device may have the same intended use and different technological characteristics if they can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regards its safety and effectiveness as compared to the predicate device.
The Lumix 3 100W Plus and Lumix 3 250W Ultra Systems have the same intended uses, and technical, functional and performance characteristics as the predicate devices listed above. The Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are designed to comply with applicable performance standards promulgated by Federal Food and Drug Administration.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
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
June 2, 2014
USA Laser Biotech Incorporated % Ms. Joyce Heinrich Texas Applied Biomedical Services 12101 Cullen Boulevard, Suite A Houston, Texas 77047
Re: K132016
Trade/Device Name: Lumix 3 100W Plus and Lumix 250W Ultra IR Laser Systems Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: May 8, 2014 Received: May 14, 2014
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 (2 l 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
6
Page 2 - Ms. Joyce Heinrich
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.goy/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. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
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 below.
510(k) Number (if known) K132016
Device Name
Lumix 3 100W Plus and Lumix 250W Ultra IR Laser Systems
Indications for Use (Describe)
The Lumix 3 100W Plus and Lumix 3 250W Ultra Systems are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperary 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)
2 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) (Signalure)
Neil R Ogden -S 2014.05.30 16:13:28 -04'00'
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."