Phoenix Thera-Lase System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a staggered formation, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Phoenix Thera-Lase Systems, LLC % Ms. Diane Rutherford Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, Texas 75080 September 4, 2015 Re: K151521 Trade/Device Name: Phoenix Thera-Lase System Model 3000 Regulation Number: 21 CFR 890.5550 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: August 5, 2015 Received: August 7, 2015 Dear Ms. Rutherford: 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 {1}------------------------------------------------ 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 Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerelv vours. Joshua C. Nipper -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ## 510(k) Number (if known) K151521 Device Name Phoenix Thera-Lase System Model 3000 Indications for Use (Describe) The Phoenix Thera-Lase System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (1/14) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for Phoenix Thera-Lase Systems, LLC. The word "Phoenix" is written in a stylized font, with the "P" being much larger than the other letters. Above the word "Phoenix" is a teal-colored image of a bird with its wings spread. Below the word "Phoenix" is the phrase "THERA-LASE SYSTEMS, LLC" in a smaller font. # 5. 510(k) SUMMARY | Submitter: | Phoenix Thera-Lase Systems, LLC<br>5454 La Sierra Drive, Suite 203<br>Dallas, Texas 75231 | |--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Mr. Gary Bellinger<br>Managing Partner<br>TEL: 469-567-3959<br>FAX: 469-726-2186<br>phoenixgb@yahoo.com | | Date Prepared: | May 27, 2014 | | Trade Name: | Phoenix Thera-Lase System | | Common Name: | Infrared heat lamp | | Classification: | ILY 890.5500 Class 2 Lamp, Infrared, Therapeutic Heating | | Predicate Device: | K120604 K-Laser ELTECH s.r.l.<br>K101893 Nexus Laser USA Laser Biotech Inc<br>K122125 ASA Laser El.En. S.p.A<br>K121363 Diowave Laser Technological Medical Advancements, Inc | | Device Description: | The Phoenix Thera-Lase System is a stand-alone, solid-state class IV laser system specifically designed to provide efficient, high-power laser output with air-cooling and an output wavelength of 1060 nm. The laser output provides a 0.75-1.88 inch diameter spot to provide non-contact laser output to patients. The laser system has three different operation modes: Continuous wave, Single, and Repeat mode.<br><br>The Laser system consists of three main components: Laser Diode Module, Remote Controller, and Fiber Optic delivery cable with hand piece. The Laser Diode Module contains the power supply system and the laser diode. The Remote Controller controls the laser module through a touch screen activated control panel. The Fiber Optic delivery cable is connected to the Laser Diode Module to provide a route for administration of the laser output. | | Statement of<br>Intended Use /<br>Indications for Use: | The Phoenix Thera-Lase System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Phoenix Thera-Lase Systems, LLC. The logo features the word "PHOENIX" in a stylized font, with the "P" and "I" in a darker green color and the rest of the letters in a lighter blue color. Above the word "PHOENIX" is a stylized image of a bird's wing or a leaf in teal and blue. Below the word "PHOENIX" is the text "THERA-LASE SYSTEMS, LLC" in a smaller font. Summary of Technological Characteristics: The Phoenix Thera-Lase System is a portable, software controlled, noncontact laser device. The laser system emits energy in the infrared spectrum with output power of 35 watts and output wavelength of 1064 nm. The laser system consists of Gallium-Aluminum-Arsenide (GaAIAs) single diode and can be operated on three different operation modes; Continuous Wave, Single and Repeat mode. Operations are controlled using an LCD touch panel to set laser output specifications. Options (e.g. mode, timer, power level, etc) can be set to provide desired parameters. Safety features are provided with the Laser system to ensure patient and user safety. These features include automatic overload and no-load trip, automatic shut off, an emergency stop button, regulated power output, and interlock functions. Testing was performed which demonstrates that the device is safe and Summary of Non-Clinical Data: effective, performs comparably to the predicate device(s), and is Test Data: substantially equivalent to the predicate device(s). Tests included verification/validation testing to internal functional specifications (including software), and non-clinical skin temperature evaluations. Documentation was provided demonstrating compliance of the Phoenix Thera-Lase System to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. > In addition, the Phoenix Thera-Lase System was subjected to independent laboratory testing for both electrical safety and electromagnetic compatibility (EMC). Test results demonstrate that the device complies with all applicable requirements for medical device electrical safety and EMC, including the following: - FDA recognized medical device electrical safety consensus standard . AAMI / ANSI ES60601-1:2005/(R)2012 And C1:2009/(R)2012 And, A2:2010/(R)2012 Medical Electrical Equipment -- Part 1: General Requirements For Basic Safety And Essential Performance, and - FDA recognized medical device EMC consensus standard IEC . 60601-1-2 Edition 3: 2007-03 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests. In accordance with the FDA guidance document Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Device, the temperature range at the skin surface where the device is applied has been evaluated and the results included within this submission. These verification/validation activities successfully demonstrate that the {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Phoenix Thera-Lase Systems, LLC. The logo features the word "PHOENIX" in a stylized, teal-colored font, with the "I" in Phoenix extended downwards. Above the word "PHOENIX" is a teal-colored graphic that resembles stylized wings or leaves. Below the word "PHOENIX" is the text "THERA-LASE SYSTEMS, LLC" in a smaller font. Phoenix Thera-Lase System correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate device(s). Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the Phoenix Thera-Lase System. - Phoenix Thera-Lase Systems, LLC considers the Phoenix Thera-Lase Conclusion: System to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.