LIGHTWAVE INFRARED LAMPS LW10D AND LW30D

{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 360-699-6197 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 303-530-4774 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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