HEALITE II SYSTEM

K113668 · Lutronic Corporation · ILY · Jun 19, 2012 · Physical Medicine

Device Facts

• Record ID: K113668
• Device Name: HEALITE II SYSTEM
• Applicant: Lutronic Corporation
• Product Code: ILY · Physical Medicine
• Decision Date: Jun 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

HEALITE II is a light-emitting diode (LED) system emitting 830 nm light for therapeutic use, supplemented by a 590 nm aiming beam. The device consists of an LED head, a base unit containing the power supply, and a control system. Operators use an integrated software interface to manage device functions. The system is intended for clinical use to provide temporary relief of minor muscle and joint pain, arthritis, and muscle spasms, while promoting muscle relaxation and local blood circulation. By delivering specific light wavelengths to the target area, the device aims to alleviate stiffness and improve circulation, potentially benefiting patients suffering from musculoskeletal discomfort.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

Light-emitting diode (LED) system; 830 nm therapeutic wavelength; 590 nm aiming beam; base unit with power supply and control system; user interface software for function control.

Indications for Use

Indicated for temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relief of stiffness; promotion of muscle tissue relaxation; and temporary increase of local blood circulation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Omnilux Plus (K043317)

Submission Summary (Full Text)

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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

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 [e-mail] Tele: 215-205-2219 FAX: [phone]

Summary Preparation Date:

May 15, 2012

2. 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).

4. Device Description

Confidential and Proprietary Information of Lutronic Corporation

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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.

7. 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 [phone] or [phone] 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