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Klim Dyachkov
Klim Dyachkov

Buy B Cure Laser

We highly recommend the B-Cure Laser Sport as part of an effective treatment for physical trauma, sports injuries and post-surgical recovery. The treatment with B-cure Laser has significantly reduced the use of anti-inflammatory medicines which are known to have many side effects.

buy b cure laser

Itay Avni, the UK Manager at B-Cure Laser, said: Chronic pain is an historic curse that we now have a technologically-advanced solution for. Our laser therapy is revolutionising the treatment of chronic pain. With our device, the consumer can take better care of themselves and their families by treating the pain at home. B-Cure Laser can treat numerous illnesses that are currently mostly treatable in medical facilities, including lower and upper back pain, knee and neck pain, carpal tunnel syndrome and more.

More than 250,000 devices have been sold across 20 countries, with the LLLT treatment pulsing near infrared 808 nanometre Ga-Al-As (Gallium-Aluminium-Arsenide) diode laser over a 4cm2 area to provide pain relief and wound healing acceleration.

Layout table for study information Study Type : Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Resource links provided by the National Library of Medicine MedlinePlus related topics: Diabetic Foot Foot Health Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease U.S. FDA Resources Arms and Interventions Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Arm Intervention/treatment Active Comparator: control group,The control group will be treated with a sham B-cure laser machine, emitting only green indicator light and no 808nm laser. Device: standard hoem treatmentAll treatments will be carried out by trained study caregivers that will give standard treatment to all the participants under their care.

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Objective: This study analyzed a home, low-level laser therapy (LLLT) protocol to manage temporomandibular joint disorders (TMJDs)-related pain.Methods: Ninety TMJD patients (12M, 78F) between 18 and 73 years were randomly subdivided into three groups. Study group (SG) received 1-week home protocol LLLT by B-cure Dental Pro: 808 nm, 5 J/min, 250 mW, 15 KHz for 8', 40 J each, over pain area, twice daily. Placebo group (PG) followed the same protocol using sham devices. Drugs group (DG) received conventional drugs. Pain was evaluated by visual analog scale (VAS) before and after therapy.Results: Statistical analysis showed that treatment was effective (F(2,83) = 4.882; p = .010). Bonferroni post-hoc analysis indicated a lower pain decrease in PG. SG registered a 34-point decrease per patient, while in PG and DG, the reduction was 25.6 and 35.3, respectively.Conclusion: The study supports the efficacy of home LLLT management of TMJD related pain.

"One of our players had sprained an ankle. I started treating him with B-Cure Laser the next day, four times a day. A few days after, he was ready to play. I believe that the B-Cure Laser treatment significantly shortened the treatment time and allowed the player to return to the field faster than it would have been possible using conventional therapy only. Now our players use B-cure Laser even during bus rides, before and after the games."

During an inspection of your firm located in Dallas, Texas from August 22, 2019 to September 5, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Curewave Medicore. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

Your firm has provided no evidence to FDA supporting the safety and efficacy of the CureWave laser devices as marketed on the websites listed above. The lack of evidence demonstrating the safety and efficacy of these claims raises public health concerns. Specifically, the risk for these devices, as advertised, is delay in definitive treatment. For example, delayed or ineffective treatment for wound care and bacterial infection can lead to loss of function, amputation, or death. Additionally, delayed or ineffective treatment for nerve damage can lead to permanent loss of function.For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency, per 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at:

c. Section 7.0 - 7.1.6 of your procedure states verification activities and tasks are completed throughout the design process. These activities are review, analysis, test, inspections, etc. and are listed in the DES/0100-4: Design Input Details. Your procedure goes on to state the design verification records will include a description of the methods (material, test, equipments, etc.) used, the results, the name(s) of the individual(s) completing the verification, and the date, recorded on form DES/0100-8: Design Verification Summary. Your firm performed various design activities including: an external skin temperature test using the Curewave Laser, skin test, laser fiber checks, etc. These design verification activities were not performed nor documented as per the design verification section 7.1.6.

5. Failure to certify, based on a test, in accordance with the standard, of the individual article to which the electronic product is attached, or upon a testing program which is in accordance with good manufacturing practices, as required by 21 CFR 1010.2(c). Specifically, your firm has not conducted a certification of its Class IV laser product based upon a test, in accordance with the standard, or testing program which is in accordance with good manufacturing practices. During the inspection, your firm acknowledged that it has not performed any tests (internally or externally) to certify the device as a Class IV laser.

6. Failure to incorporate in each Class IV medical laser product a means for the measurement of the level of that laser radiation intended for irradiation of the human body, having an error in measurement of no more than 20% when calibrated, as required by 21 CFR 1040.11(a)(1). Specifically, your firm manufactured and distributed a Class IV laser that emits 44 W at a wavelength of 1280 nm. Your firm did not incorporate a means for measuring the level of radiation in the laser product.

8. Failure to provide the full name and address of the manufacturer of the product in a label, as required by 21 CFR 1010.3(a). The label shall be permanently affixed or inscribed on the product so as to be legible and readily accessible to view when the product is fully assembled for use. However, your firm has manufactured and distributed laser products and the following information was missing from the labels:

9. Failure to submit a product report to the FDA/CDRH, prior to the introduction of a laser product into commerce, as required by 21 CFR 1002.10. For example, Curewave Lasers has manufactured and distributed 49 laser devices since 2017. However, FDA has not received initial product reports for these electronic products. FDA has also not received the subsequent annual reports, which are also required under 21 CFR 1002.13.

Low-level laser therapy (LLLT) (also known as cold laser) is a laser beam that acts on the surface of the skin and at the same time penetrates deep into the tissue with no heating effect and without damaging the skin. 041b061a72


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