Great news! Assisted Phototherapy Mask Successfully Approved for FDA 510 (k)
In the field of medical device regulatory consulting, we continue to write brilliant chapters with our professional strength and unremitting efforts. Today, exciting news came: with the full assistance of our team, the customer's LED phototherapy mask has been successfully approved for FDA 510 (k)! This achievement is not only a powerful proof of the customer's product strength, but also a vivid reflection of our consulting service professionalism and efficiency.
1. Introduction to LED Phototherapy Mask
LED phototherapy mask is a household medical beauty device mainly used for treating wrinkles on the whole face and mild to moderate acne vulgaris. It cleverly utilizes specific wavelengths of light, including blue light (415nm), red light (630nm), and near-infrared light (830nm), to work in synergy. In acne treatment mode, blue light accurately sterilizes and red light assists in skin repair; In the wrinkle treatment mode, dual light synergistically stimulates collagen production, effectively reducing wrinkles and restoring skin radiance. The product design fully considers ergonomics, with an adjustable headband and a thermal compression function around the eyes (38 ℃ -41 ℃), providing users with a comfortable user experience. This product is quite popular in the markets of China, Europe, and America. It is classified as a Class II medical device in the United States and is marketed through 510 (k) registration.
2. FDA 510 (k) registration experience for LED phototherapy mask
In the early preparation stage of writing the application documents, we conducted comprehensive and in-depth research and analysis of the product with a rigorous attitude and professional spirit. To accurately grasp the core principles of the product, we extensively consulted a large number of authoritative professional literature materials. In the vast sea of information, professional knowledge and rich experience are used to carefully extract concise and clinically based descriptions of working principles, ensuring accurate and scientific expression that can withstand strict scrutiny.
In the process of product parameters and testing, we closely integrate FDA guidelines and systematically classify products based on their structural characteristics. Conduct in-depth research on the various parameters that must be provided for this type of product, and carefully study scientific testing methods for different parameters. At the same time, strictly follow the FDA's guidelines on patient labeling and usability to carry out the design and preparation of product instructions. Not only that, but also carefully plan usability testing, covering key testing items such as tag readability, and ultimately issue professional and detailed testing reports.
For every content and document that needs to be provided, we uphold an attitude of continuous improvement, from logical structure to written expression, we have repeatedly scrutinized and carefully polished them. Strive to achieve reasonable and coherent content, clear and coherent logic, and easy to understand expression, in order to accurately grasp every detail of the product and provide comprehensive documents, laying a solid foundation for the product to pass FDA review smoothly.
3. Apply for key experience sharing
Below is a brief sharing of the problems and experiences encountered during the application process:
In the current 510 (k) application process, there are relatively few overall supplementary issues, but there are also some key points. Among them, issues related to biocompatibility, the impact of light on the eyes, and heating modules are particularly prominent.
In terms of biocompatibility, as the product is used to treat mild to moderate inflammatory acne, the FDA requires additional biocompatibility testing items related to damaged skin for this purpose. However, based on the FDA's past approval records, similar products do not have consistent practices in this regard. Some similar products have been tested for damaged skin, while others have not undergone this test. Even in the absence of testing on damaged skin using comparable devices with identical expected uses, the FDA still insists on imposing this requirement on our product. This phenomenon fully demonstrates that the FDA's requirements for biocompatibility are becoming increasingly strict, and also reflects the differences in the focus of different auditors. It is worth mentioning that our company, with rich experience and professional prediction, anticipated the possible occurrence of this issue before testing. Therefore, we conducted the test in advance according to the intradermal stimulation standard and informed the customer in advance that there may be a need to supplement the test items according to the damaged skin, making sufficient preparations for the audit.
In terms of heating modules, the FDA is highly concerned about their safety, focusing not only on the heating temperature itself, but also on the potential impact of temperature on tissues. This requires us to strictly control the heating module during product design and testing to ensure that it operates within a safe range and avoid potential harm to users.
The impact of light on the eyes is also a key focus of the review. The FDA is particularly concerned about whether the product structure can effectively prevent eye damage from light. In addition to optimizing the product structure design, equipping users with goggles that fit the product structure is also a feasible solution to comprehensively ensure the eye safety of users during use.
4. Join hands in the future and create more brilliance together
The successful approval of the LED phototherapy mask for FDA 510 (k) is another significant achievement of our consulting services. In the future, we will continue to deepen our expertise in medical device regulatory consulting, continuously improve our professional capabilities, and provide high-quality and efficient services to more customers. We look forward to working together with more enterprises to help more innovative medical devices smoothly enter the international market and contribute to the global healthcare industry.
Congratulations once again on the successful approval of the FDA 510 (k) for the LED phototherapy mask! We look forward to this product achieving outstanding results in the international market and bringing beauty and health to our users!
