ELECTRO-LIGHT THERAPY

K090250 · Hill Laboratories Co. · ILY · Feb 11, 2010 · Physical Medicine

Device Facts

• Record ID: K090250
• Device Name: ELECTRO-LIGHT THERAPY
• Applicant: Hill Laboratories Co.
• Product Code: ILY · Physical Medicine
• Decision Date: Feb 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Electro-Light Therapy System is used to provide topical heating for: - Temporary increases in local blood flow and circulation . - . Temporary relief of minor muscle and joint aches - . Temporary relief of pain and stiffness - . Relaxation of muscles - . Temporary relief (or relaxation) of muscle spasms - Temporary relief of minor pain and stiffness associated with arthritis . The Electro-Light Therapy system is intended to be used alone or at the same time with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy when used with the transparent Electro-Light electrode.

Device Story

Electro-Light Therapy is an infrared (IR) lamp system providing topical heating; used alone or concurrently with TENS, interferential, or powered muscle stimulators via transparent gel electrodes. Device supports up to 4 IR light heads; features a maximum timer setting of 99 minutes. Operated by qualified therapists in clinical settings; device mounted on a cart. IR and visible light pass through transparent electrodes to target tissue. Clinical benefit includes temporary pain relief, muscle relaxation, and increased local circulation. Operator must monitor patient during treatment to prevent overheating or patient falling asleep.

Clinical Evidence

Bench testing only. No clinical data provided. Safety validated through temperature measurements (max 45°C) and compliance with IEC 60601-1 electrical safety standards.

Technological Characteristics

Infrared therapeutic heating lamp; supports up to 4 light heads. Operates on electrical power. Designed for use with transparent gel electrodes. Complies with IEC 60601-1 (+A1, +A2) for electrical safety. Form factor is a cart-mounted system.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint aches, pain, stiffness, muscle spasms, and arthritis-related pain/stiffness, and for temporary increases in local blood flow/circulation. Intended for use by qualified therapists.

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

• HF 54 with Optional Hands-free operation (K072256)
• Terraquant Mq2000 V.5 With The Tq-1 Tens (K071445)

Submission Summary (Full Text)

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IC090250

# 510(k) SUMMARY

## For Hill Laboratories Electro-Light Therapy

FEB 1 1 2010

. . . .

#### 1. Submitter's Name and Address

| Submitter's Name: | Hill Laboratories |
|-----------------------|-------------------|
| Address: | 3 Bacton Hill Rd |
| City, State, and Zip: | Frazer, PA 19355 |

### 2. Contact Person

| Name: | Brady Aller |
|------------|-------------------------|
| Title: | Sales/Service Manager |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| E-mail: | [e-mail] |

#### 3, Manufacturing Facility Address

| Manufacturer: | Hill Laboratories |
|-----------------------|-------------------|
| Address: | 3 Bacton Hill Rd |
| City, State, and ZIP: | Frazer, PA 19355 |

#### 4. Establishment Registration Number

Establishment Registration Number: 2510425

#### 5. Reason for Submission

Reason for Submission: New Device

#### 6. Date of Summary Preparation

Date of Summary Preparation: January 26, 2009

#### 7. Device Details

Proprietary or Trade Name: Electro-Light Therapy Infrared lamp Common Name:

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### Device Common Name, Classification, Product Code & 8. CFR No.

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|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------|--------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>LINER FOR AND AND ANDRE<br>n tranda<br>12mm<br>1 | 1<br>------------------------------------- | 1 | ------------------------------------<br>890 5500 |

#### 9. Classification Name

lamp, infrared, therapeutic heating

#### Device Classification Panel 10.

Physical Medicine

#### 11. Indications for Use

Electro-Light Therapy System is used to provide topical heating for:

- Temporary increases in local blood flow and circulation .
- . Temporary relief of minor muscle and joint aches
- . Temporary relief of pain and stiffness
- . Relaxation of muscles
- . Temporary relief (or relaxation) of muscle spasms
- Temporary relief of minor pain and stiffness associated with arthritis .

The Electro-Light Therapy system is intended to be used alone or at the same time with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy when used with the transparent Electro-Light electrode.

#### Standards 12.

#### Mandatory Standards 12.1

There are no mandatory standards for the type of device contained in this 510(k).

#### 12.2 Consensus Standards

The Electro-Light Therapy is designed to comply with the following Consensus Standards:

| STANDARD NO. | TITLE |
|----------------------|--------------------------------------------------------------------------|
| IEC 60601-1 +A1, +A2 | Medical Electrical Equipment- Part 1: General Requirements for<br>Safety |

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#### 13. Predicate Devices

| 510(k) Number | Trade or Proprietary or Model<br>Name | Manufacturer | Class |
|---------------|---------------------------------------------|-----------------------|-------|
| K072256 | HF 54 with Optional Hands-free<br>operation | Hill Laboratories | 2 |
| K071445 | Terraquant Mq2000 V.5 With<br>The Tq-1 Tens | Medical Quant<br>LTD. | 2 |

#### Substantial Equivalence (SE) Rationale 13.1

### 13.1.1 Technology

The Electro-Light Therapy offers similar infrared therapy to the K072256 predicate device. The IR Light covered by K072256 allowed the operation of only one light head. The Electro-Light Therapy can support up to 4 light heads each with a similar intensity to the predicate K072256.

The significant difference between the Electro-Light Therapy device and the Terraquant Mg2000 V.5 With the Tq-1 Tens is that the predicate device K071445 is equipped with an on-board TENS stimulator. The Electro-Light Therapy device does not have a built-in TENS stimulator.

The Electro-Light Therapy device can shine its IR light through the optional transparent gel electrodes. In the case of the predicate K071445, the electrode is an annular gel electrode ring attached to the front of the IR applicator and light can shine through the middle of the electrode ring. The Electro-Light Therapy is intended be used with any legally marketed TENS, interferential, or powered muscle stimulator. The IR and visible light will pass through a clear gel electrode. The gel electrode was cleared under K072256. Like the predicate devices, the Electro-Light Therapy is intended to be used only by a qualified therapist.

Both the predicate devices and the new device are intended to be used on a cart.

### 13.1.2 Standards

The Electrical Safety of the predicate device is consistent with FDA guidance and international standards. The new device is in compliance to the same standards.

### 13.1.3 Materials

The materials used in construction of the device, including the patient contacting parts and the method of information display are similar to the predicate cleared under .

### 13.1.4 Measured Parameters

The measured parameters for the proposed Electro-Light Therapy are the similar to those displayed on the device cleared under K072256.

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### 13.1.5 Risk Analysis

The primary risks were identified as:

- . Temperatures in tissues above 45 °C
- . Patient falling asleep during treatment

#### Temperatures in Tissues 13.1.5.1

From Measurement, it was shown that the maximum temperature was 45 ℃ there is no new safety issue when compared with the K072256 predicate.

#### 13.1.5.2 Patient falling asleep during treatment

The operator's manual requires that the operator remain in the same area as the patient and must monitor the patient to ensure that the patient has not fallen asleep.

The primary difference between the new device and the predicate K072256 is that the predicate has a setting that allows continuous IR output whereas the new device has a maximum time setting of 99 minutes. This is not considered to be significant.

### 13.2 Conclusion

The proposed Electro-Light Therapy when used as directed in the operator's manual presents no new safety or effectiveness concerns and is Substantially Equivalent to the IR therapy hand-piece cleared under K072256. The Electro-Light Therapy also has same characteristics of combined electrotherapy and IR therapy as the K071445 predicate.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Hill Laboratories % Mr. Brady Aller 3 Bacton Hill Road Frazer, PA 19355

Re: K090250

Trade/Device Name: Electro-Light Therapy Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: February 2, 2010 Received: February 3, 2010

FEB 1 1 2010

Dear Mr. Aller:

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 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.

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Page 2 - Mr. Brady Aller

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
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 statement

510(k) No. If known

Device Name:

### Electro-Light Therapy

Indications For Use:

Electro-Light Therapy System is used to provide topical heating for:

- Temporary increases in local blood flow and circulation .
- . Temporary relief of minor muscle and joint aches
- . Temporary relief of pain and stiffness
- . Relaxation of muscles
- . Temporary relief (or relaxation) of muscle spasms
- . Temporary relief of minor pain and stiffness associated with arthritis

The Electro-Light Therapy system is intended to be used alone or at the same time with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy when used with the transparent Electro-Light electrode.

Prescription Use X (Per 21 CFR 801 Subpart D

Over-The-Counter Use

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation

AND/OR

luation (ODE)
FOR M.MEIKARS
Division Sign-Off

Division of Surgical, Orthopedic, 2 .d Restorative Devices

5 : 9(k) Number

Number K090250

Electro-Light Therapy 510(k)

January 26, 2009

Section 4-1