Specs & Disclosure
Technical Information and Device Specifications
Device Specs: The LuxWaves LX1000 Device is made from a flexible and durable hygienic silicone with an innovative design for comfortable of use. This device is designed to attach to the skin and held firmly against the body with a soft strap. It is waterproof and can be cleaned with a damp cloth and sterilized with a common household disinfectant. The device is also registered with the FDA and holds a CE certification, which is the gold standard of European safety and legal compliance. The LX 1000 model is specifically designed to relieve pain and accelerate the body’s natural ability to recover. EAN: 4897080 000008 FDA Listed Device Number: D316762. The LuxWaves® flexible Phototherapeutic Device alleviates back pain, neck discomfort, joint aches and muscle soreness. It is suitable to be attached to the lower back, neck, shoulder, elbow, wrist, knee, ankle, etc. to treat chronic pain, muscle stiffness, and inflammation. LuxWaves LX 1000 is registered with the FDA. Photon Wavelength: 880 nm; Photon Energy: 1.8 mW/cm2 (at standard energy level) up to 2.7 mW/cm2 (at high energy level). Classification: Risk Group 1 LED Emitting Area: 22.7 cm x 9.8 cm; Pad Weight: 175 grams; Pad Material: Silicone; Device Input: 10V DC, 1.5 A; Power Supply Class: Class II; Power Supply Input: 100– 240V; AC: 50 – 60 Hz; Power Cord Length: 2 meters; Velcro® Straps: 1 for waist sizes 28”– 42” and 1 for waist sizes 40” – 65” nylon polyester material; Operating Environment: Temperature 10° C – 35° C relative to a humidity of 30% – 90%. Tests Passed and Standards Met – EN 60601-1:2006+A1:2013; Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – EN 60601-1-11:2010; Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment – EN 60601-1-2-57:2011; Medical electrical equipment – Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use – EN 60601-1-6:2010+A1:2015; Medical electrical equipment – Part 1-6: General requirements for safety – Collateral Standard: Usability – EN 62366:2008+A1:2015; Medical devices – Application of usability engineering to medical devices – EN 60601-1-2:2007; Medical electrical equipment – Part 1-2: General Requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility (EMC) – CFR 47 FCC PART 15 SUBPART B:2014; Electromagnetic Interference (EMI) – EN ISO 10993-1:2009/AC:2010; Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process – EN ISO 10993-5:2009; Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity – EN ISO 10993-10:2013; Biological evaluation of medical devices – Tests for irritation and skin sensitization – EN 62471-5:2008; Photo biological safety of lamps and lamp systems FDA Registration and Listing Establishment Registration Number: 3014331305; Listed Device Number: D316762 FCC; Certification Certificate issued by SGS-CSTC; In conformity with CFR 47 FCC PART 15 SUBPART B:2014; CB Certification Certificate issued by SGS Fimko; In conformity with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1-11:2010, IEC 60601-2-57:2011, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013; Certifications in Progress ISO 13485 Quality Management System, Medical CE. Disclaimers and Considerations *It is recommended that the PBM devices not be used directly on any neo-plasmic tissue. *Do not put red light on insect bites, plant generated rashes, or any other venom or poison-related skin inflammations. *Do not shine the light into the eyes for length of time. Pregnant women should also refrain from PBM treatments over the abdomen. *People with pacemakers or any other electrical devices in their body should not apply PBM treatments anywhere near the area where the internal device is located. LuxWaves light therapy is registered with the FDA. However, the health benefits mentioned in this website are for “educational purposes” only and are not meant to diagnose, treat, cure, or prevent disease. The information presented herein is based on peer-reviewed clinical research. This website was designed to educate interested readers about the science, research, and specific health applications of light therapy as currently understood. However, if you have been diagnosed with a serious illness and/or disease of any kind, you should first consult your primary doctor or trusted healthcare professional prior to any treatment protocol of your medical condition(s) to determine whether light therapy is right for you. All information provided in documents, websites, videos, audio broadcasts, or by LuxWaves employees should not be construed as medical advice. Any reviews presented are only applicable to the individual depicted and may not represent the actual views of LuxWaves. Individual results may vary. Copyright © 2020 LuxWaves, LLC. All Rights Reserved.
Matt DeBow ⓒ 2019 • LuxWaves.com