(189 days)
Not Found
No
The description focuses on LED technology and a standard control system, with no mention of AI or ML terms or functionalities.
Yes
The device is intended for the temporary relief of pain and stiffness, and to promote relaxation and increase blood circulation, which are all therapeutic effects.
No
The device is described as providing temporary relief of pain, stiffness, and promoting relaxation and increased blood circulation. It is not described as identifying or classifying a disease or condition.
No
The device description explicitly states it is a "light emitting diode (LED) system" with an "LED head," a "base unit" containing a "power supply and control system." While it includes user interface software, it is clearly a hardware-based device with software controlling its functions.
Based on the provided information, the HEALITE II system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for therapeutic purposes (pain relief, muscle relaxation, increased blood circulation) by applying light to the body. This is a direct interaction with the patient's body for treatment.
- Device Description: The device is described as an LED system that emits light at a specific wavelength. This is a physical device used for light therapy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening. The core function is applying light to the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. The HEALITE II system does not fit this description.
N/A
Intended Use / Indications for Use
The HEALITE II system is intended for the following: For use in temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and to temporarily increase local blood circulation where applied.
Product codes
ILY
Device Description
The HEALITE Hesystem is a light emitting diode (1) ED) with high-spectral purity - Thissystem is packaged with an LED head for the particular intended use of the system. The wavelength of the HEALITE II is 830 nm. Additionally there is a 590 nm aiming beam. The base unit contains power supply and control system. The user interface software allows the operator to access and control all device functions.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None presented.
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.
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Page Wofir
510(k) Summary for the Lutronic-Corporation-HEALITE-II-
This 510(k) Summary is being submitted in accordance with the requirements of the JUN 1 9 2012 SMDA 1990 and 21 CFR 807.92.
1. General Information
Submitter:
Contact Person
f
Lutronic Corporation Room 403-1, 2, 3, 4, 5, 404 Ilsan Technotown 1141-1 Baekseok-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, 410-722 Republic of Korea
Jhung Won Vojir, Ph.D. Chief Executive Officer Lutronic, Inc. Six Neshaminy Interplex, Suite 207 Trevose, PA 19053 jvojir@lutronic.com Tele: 215-205-2219 FAX: 609-488-6958
Summary Preparation Date:
May 15, 2012
- Names
Device Name:
HEALITE II
Classification Name:
Laser instrument, surgical, powered device: GEX, ILY FDA Class II category
Although this device is not a laser, the manufacturer believes this is the closest applicable classification name.
3. Predicate Devices
The HEALITE II system is substantially equivalent to the Omnilux Plus (K043317).
- Device Description
Confidential and Proprietary Information of Lutronic Corporation
14
1
K113668 Page (2) -f(2)
The HEALITE Hesystem is a light emitting diode (1) ED) with high-spectral purity - Thissystem is packaged with an LED head for the particular intended use of the system. The wavelength of the HEALITE II is 830 nm. Additionally there is a 590 nm aiming beam. The base unit contains power supply and control system. The user interface software allows the operator to access and control all device functions.
5. Indications for Use
The HEALITE II system is intended for the following:
For use in temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and to temporarily increase local blood circulation where applied.
6. Substantial Equivalence
The HEALITE II system is substantially equivalent to the Omnilux Plus (K043317). The intended use and technological characteristics of the HEALITE II system are virtually identical to the intended use and technological characteristics of the predicate devices. Any differences between the HEALITE II and the equivalent devices have no significant influences on safety or effectiveness of the HEALITE II system. Therefore, the HEALITE II system is substantially equivalent the predicate systems.
- Performance Data None presented.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three tail feathers. The bird is positioned above a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
JUN 1 9 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Lutronic Corporation % Lutronic Inc. Jhung Won Vojir, Ph.D. CEO 6 Neshaminy Interplex, Suite 207 Trevose Pennsylvania 19053
Re: K113668 Trade/Device Name: Healite II System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: June 04, 2012 Received: June 05, 2012
Dear Jhung Won Vojir:
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.
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Page 2 - Jhung Won Vojir
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 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 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, Mark N. Melkerson
Dist Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K113668 |
|---|---|
| Device Name: HEALITE II |
Indications for Use:
The HEALITE II is intended for the following:
For use in temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and to temporarily increase local blood circulation where applied.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (Part 21 CFR 801 Subpart C)
(PLEʿASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(ODE)
Neil RPDighe formxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
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Confidential and Proprietary Information of Lutronic Corporation
510(k) Number K113668