LIGHTWAVE INFRARED LAMPS LW10D AND LW30D

K024027 · Skytech Enterprises, Inc. · ILY · Dec 3, 2003 · Physical Medicine

Device Facts

• Record ID: K024027
• Device Name: LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
• Applicant: Skytech Enterprises, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Dec 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide infrared light energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles and relief from pain resulting in improved range of motion

Device Story

LightWave Infrared Photon Stimulator (models LW10D, LW30D) is an infrared lamp for topical heating. Device uses LEDs emitting 940 nm wavelength to generate heat. LW10D uses 9 LEDs (20 mW output) powered by 9V battery or 110V AC adapter; LW30D uses 30 LEDs (30 mW output) powered by 110V AC adapter. Both models utilize 145 Hz pulse. Intended for over-the-counter use to provide temporary pain relief and muscle relaxation. Healthcare providers or patients apply device to skin; heat energy penetrates tissue to increase local circulation. Benefits include temporary relief of minor aches, pains, and stiffness, and improved range of motion. Safety is managed via design and labeling; power adapters are UL listed.

Clinical Evidence

Bench testing only. Performance testing verified that devices safely raise skin temperature according to manufacturer instructions. Risk analysis performed per EN1441 to identify and mitigate potential hazards.

Technological Characteristics

Infrared lamp; 940 nm wavelength LEDs; 145 Hz pulse; LW10D (9 LEDs, 20 mW, 9V battery/AC); LW30D (30 LEDs, 30 mW, AC only); UL listed power adapters; Class II device.

Indications for Use

Indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, and muscle spasms; promotes muscle relaxation and improved range of motion via increased local blood flow and 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

• TDP Infrared Heating Lamp (K020851)
• BioScan, Inc. Infrared Lamp Spinal Pad (K993684)

Submission Summary (Full Text)

{0}------------------------------------------------

Ko24027

## 510(k) Summary Infrared Lamp, Models LW10D and LW30D

Skytech Enterprises, Inc. 2425 N.W. 69th Street Vancouver, WA 98665 360-699-6194 Telephone [phone] Fax Douglas Greene, Chairman

Prepared 11/25/02 by: L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 Telephone [phone] Fax

{1}------------------------------------------------

Device: LightWave™ Infrared Photon Stimulator, Models, LW10D and LW30D

Common Name: Infrared Lamp

Classification: 890.5500, 89 ILY, Class II

## SE Predicates:

- a) C&H International K020851, Infrared Heating Lamp TDP Heat Lamp
- b) BioScan, Inc. K993684, Infrared Lamp Spinal Pad

## Device Description:

The devices are a family (models) of infrared lamps having the same indication for use and equivalent technology. The units are electrical and mechanical designs for use and convenience of users to provide topical heating. Heat is generated by LEDs (light emitting diodes) at 940 nm wavelength. .

{2}------------------------------------------------

| Model | Number of LEDs | Output Power | Wavelength | Power Source | Light Pattern | Treatment Area | Battery Life | Recommended Treatment |
|-------|----------------|--------------|------------|-----------------------------------------|---------------|----------------|----------------------|-----------------------|
| LW10D | 9 | 20 mW | 940 nm | 9V DC battery or 110V AC/9V DC adapter | 145 Hz pulse | ~225 square mm | 6 hours continuous | 15 minutes |
| LW30D | 30 | 30 mW | 940 nm | 110V AC/9V DC adapter only (no battery) | 145 Hz pulse | ~900 square mm | 30 hours pulsing N/A | 10 minutes |

Tech Infrared Photon Stimulator Model Differentiati

ntended Lise:
If orovide intract light ears the skin o promote increased blood for and circulation, thereby, providing
emprary relef of minor musele ad join pain resulting n

{3}------------------------------------------------

## SE Comparison:

# Comparative Information

:

| Model LW10D | Model LW30D | TDP Infrared Lamps<br>K020851 | The LightPatch<br>K993684 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ILY<br>Skytech | ILY<br>Skytech | ILY<br>C&H Intl.<br>Houston, TX | ILY<br>BioScan, Inc.<br>Corrales, NM |
| Infrared light<br>energy to promote<br>increased blood<br>flow and circu-<br>lation, providing<br>temporary relief of<br>minor muscle and<br>joint pain and<br>stiffness, minor<br>arthritis pain, and<br>muscle spasm.<br>Promotes<br>relaxation of<br>muscles and relief<br>from pain resulting<br>in improved range<br>of motion. | Infrared light<br>energy to promote<br>increased blood<br>flow and circu-<br>lation, providing<br>temporary relief of<br>minor muscle and<br>joint pain and<br>stiffness, minor<br>arthritis pain, and<br>muscle spasm.<br>Promotes relaxation<br>of muscles and<br>relief from pain<br>resulting in<br>improved range of<br>motion. | Temporary relief of<br>minor muscle and<br>joint pain and<br>stiffness, the<br>temporary relief of<br>minor joint pain<br>associated with<br>arthritis, the temporary<br>increase in local<br>circulation where<br>applied, and relaxation<br>of muscles. Help<br>muscle spasms, minor<br>sprains, and minor<br>muscular back pain. | Personal comfort,<br>temporary relief of<br>minor aches and pains<br>in muscles and joints.<br>Aids in relaxation in<br>muscles, temporary<br>infrared range and<br>freedom of motion,<br>temporary minor pain<br>relief, temporary<br>increase in local blood<br>circulation. |
| Yes | Yes | Yes | Yes |
| Yes | Yes | Yes | Yes |
| 9V DC battery or<br>110V AC adapter,<br>UL listed | 110V AC adapter<br>(only), UL listed | 110V AC | 9V DC battery |
| 940 nm | 940 nm | 940 nm | 940 nm |
| ~225 square mm | ~900 square mm | ~1215 square mm | ~6500 square mm |

:

{4}------------------------------------------------

## 510(k) Substantial Equivalence Rationale:

- 1. The Skytech devices have the same indications for use as the predicate devices, TDP Infrared Lamp and the LightPatch.
- The same technological characteristics are used for this device and the two 2. predicates. All are based on the mode of operation that light emitting diodes convey heat energy to the skin. The device LEDs all operate at 940nm.
- 3. The comparative information shown in this submission demonstrates substantial equivalence for indications for use, design, and mode of operation.

## Nonclinical Data:

A Risk Analysis was performed on all models using EN1441. Potential hazards are identified and have been mitigated by design and labeling.

The devices were tested for performance and found to raise skin temperature safely when used following the manufacturer's instructions. The rise in skin temperature results in the indications for use.

Adapters to convert 110V power to 9V or 12V are UL listed to assure user safety.

## Conclusions:

These infrared lamp models are designed, labeled, and verified for performance and safety. The design has been tested and verified to raise the skin temperature adequately to effect the indications for use. A Risk Analysis confirms the design process and final product design for consideration of potential hazards. The potential hazards have been adequately addressed and mitigated by the design or by labeling. Labeling covers the user instructions and warning statements for users.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three wavy lines that resemble an abstract representation of the American flag.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2003

Skytech Enterprises, Inc. C/o Mr. Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado O 80301

Re: K024027

Trade/Device Name: Lightwave Infrared Lamps LW10D and LW30D Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 15, 2003 Received: October 21, 2003

Dear Mr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments. or to commerce proc to May 20, 1978, the enoveance with the provisions of the Federal Food, Drug, devices mat have been rechtsined in quire approval of a premarket approval application (PMA). and Cosmetter (110) that Lo neview, subject to the general controls provisions of the Act. The Tou may, dierettle, mains of the Act include requirements for annual registration, listing of general controls profitation practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassinod tional 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 I lease be advised that I Drivisante a vour device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I catal states and registanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Lat 007); adoling (Dr OS) regulation (21 CFR Part 820); and if applicable, the electronic ford in the quarty by wisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{6}------------------------------------------------

Page 2 - Mr. Lewis Ward

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and wy and finding of substantial equivalence of your device to a legally premance hotification. The a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spocific acrios 101 your as [phone]. Also, please note the regulation entitled, Connact the Office of Comments to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours,

Mark N Millerm

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Initial 510(k):

Device Name:

Indications for Use:

Janf

To provide infrared light energy that penetrates the skin to promote increased 1 of provide and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles and relief from pain resulting in improved range of motion

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sign-Off)
ision of General, Restorative
and Neurological Devices

Number. K024027

Prescription Use **__** OR Over-the-Counter Use **X**
(Per 21 CFR 801.109)

4