(211 days)
Not Found
No
The description focuses on the physical components and function of an infrared lamp, with no mention of AI or ML capabilities.
Yes
The device is intended to provide topical heating for the purpose of elevating tissue temperature to relieve pain, stiffness, and muscle spasm, which are therapeutic effects.
No
The device is described as an infrared heat lamp for therapeutic purposes (pain relief, increased circulation, muscle relaxation) by emitting energy to elevate tissue temperature, not for diagnosis.
No
The device description explicitly states it consists of a hardware component, a handpiece containing the controller, user interface display, and treatment aperture. It also describes the physical mechanism of action (emitting infrared light via an IR diode).
Based on the provided information, the L-SER-KO IR Lamp is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the skin surface of the human body for therapeutic purposes (pain relief, increased blood circulation, muscle relaxation). This is a direct interaction with the human body, not an examination of specimens taken from the body.
- Device Description: The description details a non-invasive device that emits light energy to the skin. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing specimens from the human body.
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in a laboratory setting for diagnostic purposes.
Therefore, the L-SER-KO IR Lamp falls under the category of a therapeutic device that interacts directly with the human body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The L-SER-KO IR Lamp 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, 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 L-SER-KO IR Lamp (Figure 8.0) is intended for use as an infrared heat lamp. The L-SER-KO IR Lamp is a non-invasive device that emits light energy to the skin surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature.
The L-SER-KO IR Lamp delivers an invisible laser beam in the infrared spectrum at wavelengths of 810 nm using a gallium aluminum arsenide (GaAlAs) source. The laser beam is generated by an IR diode. The tissue to be treated is illuminated by non-therapeutic red LED guide lights.
The L-SER-KO IR Lamp consists of only one hardware component, a handpiece containing the controller, user interface display and the treatment aperture.
The handpiece is made of standard medical PVC material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the L-SER-KO IR Lamp includes functional performance testing and electrical safety testing. The L-SER-KO IR Lamp is manufactured to comply with the following international standards:
- 21 CFR 1010 Performance Standard for Electronic Products, General
- 21 CFR 1040 - Performance for Light-emitting Products
- Medical Electrical Equipment, Part 1, EN 60601-1:2001 General Requirements for Safety
- EN 60601-1-2:2001 Medical Electrical Equipment, General . Requirement for Safety. Electromagnetic Compatibility
- ISO 14971 Medical Devices: Application of Risk Management
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
510(k) Premarket Notification L-SER-KO IR Lamp July 12, 2011
510(k) Summary (as per 21 CFR 807.92) 8.0
I. GENERAL INFORMATION
Device Generic Name:
Trade Name:
Section I
Device Classification:
FEB 1 0 2012
Infrared Lamp
L-SER-KO IR Lamp
Class II, Performance Standards 21CFR Part 890.5500 - Infrared Lamp
Product Code:
ILY
Applicant Name and Address: YA-MAN LTD
Shingu Bldg. 4F. 2-4-2 Toyo Koto-Ku, Tokyo 135-0016 Japan
510(k) Number:
Pending
II. DEVICE DESCRIPTION
The L-SER-KO IR Lamp (Figure 8.0) is intended for use as an infrared heat lamp. The L-SER-KO IR Lamp is a non-invasive device that emits light energy to the skin surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature.
The L-SER-KO IR Lamp delivers an invisible laser beam in the infrared spectrum at wavelengths of 810 nm using a gallium aluminum arsenide (GaAlAs) source. The laser beam is generated by an IR diode. The tissue to be treated is illuminated by non-therapeutic red LED guide lights.
The L-SER-KO IR Lamp consists
Image /page/0/Figure/21 description: This image is a figure that is labeled as "Figure 8.0 L-SER-KO IR Lamp". The text is black and the background is white. The text is centered in the image.
Image /page/0/Picture/22 description: The image shows a handheld device, possibly a laser hair removal tool, on a white surface. The device is white with a gray display screen and several buttons. A power cord is attached to the back of the device. The device has a rectangular head with a transparent window.
of only one hardware component, a handpiece containing the controller, user interface display and the treatment aperture.
The handpiece is made of standard medical PVC material.
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III. INDICATIONS FOR USE
The L-SER-KO IR Lamp 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, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
IV. Predicate Devices
The L-SER-KO IR Lamp is substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. These predicate devices include, but are not limited to, the USA Laser Biotech Inc. LUMINA 1600 Infrared Lamp Therapy System (K052814), and Avicenna ALT Laser Model VTR 75 (K031612).
| Characteristic | L-SER-KO IR
Lamp | Lumina 1600 IR
Heat Lamp
System | Avicenna ALT
Laser Model
VTR 75 |
|--------------------------|-----------------------------------|---------------------------------------|---------------------------------------|
| Manufacturer | YA-MAN LTD | Fisioline S.n.c, di
Battagliotti | Avicenna Laser
Technology, Inc. |
| 510k Accession
Number | Pending | K052814 | K031612 |
| Power Supply | 115V single-
phase
50-60 Hz | 120V
50 - 60 Hz | 120V
50-60 Hz |
| Heat Source | GaAlAs diode | GaAlAs diode | GaAlAs diode |
| Wavelength | 665/810 nm | 665/808 nm | 660/980 nm |
| Average Power
Output | 1.2 W | 1.6 W | 1.0 - 7.5 W |
| Treatment Mode | Modulated | Modulated | Modulated |
| Treatment Times | Variable | Variable | Variable |
| Delivery System | Diode | Fiberoptic cable /
handheld probe | Fiberoptic cable /
handheld probe |
Table 8.0 Predicate Comparison Chart
V. Summary of the Technical Characteristics of the L-SER-KO IR Lamp as Related to the Referenced Predicate Devices.
The L-SER-KO IR Lamp and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared light sources to generate topical heating for the purpose of
2
elevating tissue temperatures for temporary relief of muscle and joint pain.
VI. Testing
Testing of the L-SER-KO IR Lamp includes functional performance testing and electrical safety testing. The L-SER-KO IR Lamp is manufactured to comply with the following international standards:
- 21 CFR 1010 Performance Standard for Electronic Products, ● General
- � 21 CFR 1040 - Performance for Light-emitting Products
- Medical Electrical Equipment, Part 1, EN 60601-1:2001 � General Requirements for Safety
- EN 60601-1-2:2001 Medical Electrical Equipment, General . Requirement for Safety. Electromagnetic Compatibility
- . ISO 14971 Medical Devices: Application of Risk Management
VII. Conclusions
Pursuant to the testing and comparison to the predicate devices. the L-SER-KO IR Lamp has the same intended uses, with similar functional and performance characteristics. The .L-SER-KO IR Lamp is designed to comply with applicable performance standards promulgated by Federal Food and Drug Administration. The L-SER-KO IR Lamp performs as intended and does not raise any new safety or efficacy issues.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle's perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ya-Man Ltd. % Clinical Technologies Research Nelson Marquina, Ph.D. 9210 Forest Hill Avenue, Suite B3 Richmond, Virginia 23235
Re: K112016
Trade/Device Name: L-Ser-Ko IR Lamp Regulation Number: 21 CFR 890.5740 Regulation Name: Powered heating pad Regulatory Class: Class II Product Code: ILY Dated: February 04, 2012 Received: February 06, 2012
Dear Dr. Marquina:
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
FEB 1 0 2012
4
Page 2 - Nelson Marquina, Ph.D.
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section I
7.0 Indications for Use Statement
Pending 1/12016 510(k) Number:
L-SER-KO IR Lamp Device Name:
Indications for Use:
The L-SER-KO IR Lamp 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, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
AND/OR Over the Counter Use: Prescription Use: X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODpE)
Nilke Ogden for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112016