L-SER KO LAMP

K112016 · Ya-Man, Ltd. · ILY · Feb 10, 2012 · Physical Medicine

Device Facts

• Record ID: K112016
• Device Name: L-SER KO LAMP
• Applicant: Ya-Man, Ltd.
• Product Code: ILY · Physical Medicine
• Decision Date: Feb 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

L-SER-KO IR Lamp is a non-invasive, handheld infrared heat lamp; utilizes GaAlAs diode to emit 810 nm infrared laser energy; includes non-therapeutic red LED guide lights for targeting. Device consists of a single handpiece containing controller, user interface, and treatment aperture. Operated by user to deliver energy to skin surface; elevates tissue temperature to provide therapeutic relief. Intended for temporary relief of minor muscle/joint pain, stiffness, arthritis pain, muscle spasm, and muscle relaxation; also promotes local blood circulation. No complex software or cloud connectivity described.

Clinical Evidence

Bench testing only. Functional performance and electrical safety testing conducted to verify compliance with EN 60601-1, EN 60601-1-2, and 21 CFR 1010/1040 standards. No clinical data provided.

Technological Characteristics

Handheld device; medical PVC construction. Energy source: GaAlAs diode (810 nm). Treatment mode: Modulated. Power supply: 115V, 50-60 Hz. Standards: EN 60601-1 (safety), EN 60601-1-2 (EMC), ISO 14971 (risk management), 21 CFR 1010/1040 (radiation control).

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain, stiffness, minor arthritis pain, muscle spasm, increased local blood circulation, or muscle relaxation.

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

• LUMINA 1600 Infrared Lamp Therapy System (K052814)
• Avicenna ALT Laser Model VTR 75 (K031612)

Submission Summary (Full Text)

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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

K112016

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<br>Lamp | Lumina 1600 IR<br>Heat Lamp<br>System | Avicenna ALT<br>Laser Model<br>VTR 75 |
|--------------------------|-----------------------------------|---------------------------------------|---------------------------------------|
| Manufacturer | YA-MAN LTD | Fisioline S.n.c, di<br>Battagliotti | Avicenna Laser<br>Technology, Inc. |
| 510k Accession<br>Number | Pending | K052814 | K031612 |
| Power Supply | 115V single-<br>phase<br>50-60 Hz | 120V<br>50 - 60 Hz | 120V<br>50-60 Hz |
| Heat Source | GaAlAs diode | GaAlAs diode | GaAlAs diode |
| Wavelength | 665/810 nm | 665/808 nm | 660/980 nm |
| Average Power<br>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 /<br>handheld probe | Fiberoptic cable /<br>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

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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.

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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

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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 [phone] or [phone] 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

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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