510(k) Sumnmary for the-L-utronic-C-orporation-HAITEi
This 510(k) Summary is being submitted in accordance with the requirements of theJN1921

SMDA 1990 and 21 CFR 807.92.

JN121

1. General Information
Submitter:

Lutronic Corporation
Room 403-1, 2, 3, 4, 5, 404 llsan Technotown
1141 -1 Baekseok-dong, IlIsandong-gu,
Goyang-si, Gyeonggi-do, 410-722
Republic of Korea

Contact Person

Jhung Won Vojir, Ph.D.
Chief Executive Officer
Lutronic, Inc.
Six Neshaminy Interplex, Suite 207
Trevose, PA 19053
ivoiirfllutronic.com
Tele: 215-205-2219
FAX: 609-488-6958

Summary Preparation Date:

May 15, 2012

2. Names
Device Name:HEALITE 11Classification Name:

Laser instrument, surgical, powered device:
GEX, ILY
FDA Class 1I category
Although this device is not a laser, themanufacturer believes this is the closest
applicable classification name.

3. Predicate Devices
The HEALITE 11 system is substantially equivalent to the Omnilux Plus (K0433 17).

4. Device Description

Confidential and Proprietary Informnation of Lutronlo Corporation

14

Thle-H EAL-IT-E--sysemis-a-ightenitting-diode-tL-ED)-with-high-spectral-purit-y-T-hissystem is packaged with an LED head for the particular intended use of the system. Thewavelength of the HEALITE His 830 un. 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 11 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 11 system is substantially equivalent to the Omnilux Plus (K0433 17). The
intended use and technological characteristics of the HEALITE 11 system are virtually
identical to the intended use and technological characteristics of the predicate devices.
Any differences between the 1-EALITE I1and the equivalent devices have no significant
influences on safety or effectiveness of the HEALITE 11 system. Therefore, theHEALITE 11 system is substantially equivalent the predicate systems.

7. Performance Data

None presented.

Confidential and Proprietary Infornnation of Lutronic Corporation

15

DEPARTMENT OF HEALTH & HUMAN SERVICES'5

Public Health Service

Food and Drug Administration

JUN 1 9 2012

10903 Newv Hampshire Avenue
Document Control Room -W066-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: K1 13668
Trade/Device Name: Healite 11 System
Regulation Number: 21 CFR 890.5500
Regulation Name: Infrared Lamp
Regulatory Class: 11
Product Code: ILY
Dated: June 04, 2012
Received: June 05, 2012
Dear Jhung Won Vojir:
We have reviewed your Section 5 10(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 todevices 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 ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. 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 11 (Special Controls) or class III (PMA), it
may be subject to additional controls. Existing major regulations affecting your device can befound 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.

Page 2 - Jhung Won Vojir
Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CER Part 801); medical device reporting (reporting of medicaldevice-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 80 1), please
go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDPHOffices/ucm 115809.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" (2 1CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go to
http://ww~w. fda.gov/MedicalDevices /Safety/ReportaProblem/default.htm for the CDRH's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.
You m~ay obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet address
hutp://www.fda.gov/MedicalDevices/ResourcesforYou[lndustr/default.htm.
Sincerely yours,

Mark N. MelkersorP%>
Director
Division of Surgical, Orthopedicand Restorative Devices
Office of Device Evaluation
Center for Devices andRadiological Health
EnclosureIndications for Use

510(k) Number (if known):K)IS(Device Name: H4EALITE 11

Indications for Use:
The HEALITE 11 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 CER 801 Subpart D)

AND/OR

Over The Counter Use(Part 21 CFR 801 Subpart C)__(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGEWF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE.

(Division Sign-oil)
Division of Surgical, Orthopedic,and Restorative Devices
1Confidential and Proprietary Information of Lutronic Corporation

5I1O(k) Number

KI134