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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Lutronic Corporation HEALITE II device. The key takeaway regarding acceptance criteria and supportive studies is explicitly stated: "Performance Data: None presented."

This means the submission does not include direct clinical performance data or studies to establish acceptance criteria for the device itself. Instead, the fundamental argument for clearance is based on substantial equivalence to a predicate device.

Therefore, for almost all the requested information, the answer is "not applicable" or "not provided" based on the document.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not applicable	Not applicable

Explanation: The document states "Performance Data: None presented." This implies that specific, measurable acceptance criteria based on studies, along with corresponding performance outcomes, were not part of this 510(k) submission. The clearance was based on substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No test set data was presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set data was presented, and therefore no ground truth was established by experts for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set data was presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No clinical studies, including MRMC studies, were presented. The device is a physical light therapy device, not an AI diagnostic tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The HEALITE II is a physical light therapy device, not an algorithm, so "standalone" performance in the context of AI algorithms is not relevant here. No performance studies were conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No performance data or ground truth was established or used in this submission. The basis for clearance was substantial equivalence to a predicate device.

8. The sample size for the training set

Not applicable. No training set was used. This device is a medical device, not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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K113668

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

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

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K113668 Page (2) -f(2)

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:

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

Confidential and Proprietary Information of Lutronic Corporation

510(k) Number K113668

Regulation Number and Section

§ 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.