MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM

K102134 · United Integrated Services Co., Ltd. · ILY · Dec 23, 2010 · Physical Medicine

Device Facts

• Record ID: K102134
• Device Name: MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM
• Applicant: United Integrated Services Co., Ltd.
• Product Code: ILY · Physical Medicine
• Decision Date: Dec 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Multi-Channel Laser Therapy System (Model no.: LA-1200) 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 the joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.

Device Story

The LA-1200 is a noninvasive, portable therapeutic laser system delivering light energy to target tissues. It utilizes twelve channels, each featuring a handheld cup containing a laser diode assembly. The device emits two wavelengths: 660nm (visible red light) and 808nm (invisible infrared light). The operator places the laser module cups directly onto the patient's skin. The system functions by delivering light energy to elevate tissue temperature, providing topical heating for pain relief, increased local circulation, and muscle relaxation. It is intended for clinical use to assist healthcare providers in managing musculoskeletal discomfort. The device operates by maintaining a skin temperature of 40–45°C following 15 minutes of exposure.

Clinical Evidence

Bench testing only. Testing demonstrated the device increases skin temperature and maintains it between 40–45°C (104–113°F) after 15 minutes of exposure. Conformance to ISO 13485, IEC 60825-1, IEC 60601-1, and IEC 60601-1-2 standards was verified.

Technological Characteristics

Portable, noninvasive laser therapy system. Features 12 channels with handheld cup/laser diode assemblies. Wavelengths: 660nm (red) and 808nm (infrared). Standards: ISO 13485, IEC 60825-1 (laser safety), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain and stiffness, minor joint pain associated with arthritis, temporary increase in local circulation, and 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

• Multi-Channel Laser Therapy System, MODEL LA-400 (K082686)

Submission Summary (Full Text)

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DEC 2 3 2010

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

### Submitter's Name: United Integrated Services Co., Ltd. 1

| 1. Submitter's Name: United Integrated Services Co., Ltd. | |
|-----------------------------------------------------------|-------------------------------------------------------------|
| Address: | 8F, No. 4, Alley 1, Lane 235, PaoChiao Road, Hsintien City, |
| | Taipei Hsien, TAIWAN, 23144 |
| Phone: | [phone] ext 301 |
| Mobile Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Mr. David O. Chang / Vice President |
| Contact E-mail: | [e-mail] |
| Prepare Date : | May 24,2010 |
| 2. Device Name: | |
| Trade Name: | Multi-Channel Laser Therapy System, |
| | Model no.: LA-1200 |
| Common Name: | Laser Therapy |
| Classification name | lamp, infrared, therapeutic heating |
| 3. DEVICE CLASS | The Multi-Channel Laser Therapy System, |
| | (Model no.: LA-1200) has been classified as |
| | Regulatory Class: II |
| | Product Code: ILY |

Requlation Number: 21CFR 890.5550

4. Predicate Device:

5. Intended Use:

The predicate device is the Multi-Channel Laser Therapy System, MODEL LA-400 (K082686) marketed by United Integrated Services Co., Ltd.

The Multi-Channel Laser Therapy System (Model no.: LA-1200) 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 the joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.

6. Device Description: The Multi-Channel Laser Therapy System LA-1200 is a noninvasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. It is intended to emit energy in the infrared spectrum for the purpose of temporary relief of minor muscle and the joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.

Product: Multi-Channel Laser Therapy System, Model #: LA-1200 2010/12/03 REV. (B) Section 5 - 510(k) Summary Page 1 of 2

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LA-1200 is the low level laser of two wave bands. One is 660nm (red light, visibility) and the other is 808nm (infrared light, invisibility).

LA-1200 contains twelve (12) channels of laser. For each channel of the Multi-Channel Laser Therapy System, LA-1200 makes use of cup + laser diode assembly hand-held to deliver the light energy to the designated treatment areas. The cup_ + laser diode assembly are put on the skin for treatment.

Note A : Basic operation and treatment of LA-1200 is utilizing the laser module mounted in the cup (we call faser module cup) which will be hand-held and put on skin easily.

7. Performance In terms of operating specification, Safety & EMC Summary: requirements, the device conforms to applicable standards included ISO 13485, IEC 60825-1, IEC 60601-1 and IEC 60601-1-2 requirements.

> As shown from the Appendix 11-8 to Appendix 11-13, the bench testing was also performed to demonstrate that the Multi-Channel Laser Therapy System (Model no.: LA-1200) increases the temperature of the skin exposed to the laser module cup and maintains a skin temperature of 40 ~ 45°C (104 ~ 113°(' ) following 15 minutes exposure to the light.

## 8. Conclusions:

The Multi-Channel Laser Therapy System (Model no.: LA-1200) has the same intended use and similar technological characteristics as the Multi-Channel Laser Therapy System, MODEL LA-400 (K082686) marketed by United Integrated Services Co., Ltd. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new guestions of safety or effectiveness. Thus, the Multi-Channel Laser Therapy System (Model no.: LA-1200) is substantially equivalent to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

United Integrated Services Corporation Ltd. % Mr. David O. Chang Vice President 8F, No. 4, Alley 1, Lane 235 Paochiao Road, Hsintien City Taipei Hsien, Taiwan, R.O.C. 23144

DEC 2 3 230

Re: K102134

Trade/Device Name: Multi-Channel Laser Therapy System Model no .: LA-1200 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: December 14, 2010 Received: December 17, 2010

Dear Mr. Chang:

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. Iisting 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.

Comments of Children

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Page 2 - Mr. David O. Chang

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 Patt 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.

Aj B. Rh

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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# Indications for Use

510(k) Number (if known): K102134

Device Name: Multi-Channel Laser Therapy System Model no.: LA-1200 United Integrated Services Co. Ltd.

Indications for Use:

The Multi-Channel Laser Therapy System (Model no.: LA-1200) 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 the joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Az : B. Rh In 17x17

(Division Sign-Ong Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K102134