Wakelife's LED Therapy Mask Officially Receives FDA 510(k) Spazio
We are proud to announce a pivotal milestone in our history of innovation. Wakelife’s flagship LED Light Therapy Mask has successfully received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
This achievement is publicly verifiable on the official FDA database under submission number K250830.
This is more than just a certificate; it is a testament to our unwavering commitment to product safety, efficacy, and regulatory excellence. For our partners—the skincare brands, retailers, and distributors we serve—this clearance signifies an opportunity to confidently bring a best-in-class, medically-recognized device to market.
How to search for an LED facial mask’s FDA 510(K) report
Open the FDA website to the 510(K) search page: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
Enter the number K250830 and click search to display the complete FDA 510(K) report.
Why FDA 510(k) is the Gold Standard in Beauty Tech
For those unfamiliar with the regulatory landscape, the term “FDA 510(k) spazio” might seem complex. In simple terms, it is the primary pathway for Class II medical devices, which carry a moderate level of risk, to be legally marketed in the United States. It is a rigorous, demanding process that separates truly vetted devices from the vast market of unverified gadgets.
The core principle of a 510(k) submission is demonstrating Substantial Equivalence (SE). This requires us to provide the FDA with extensive scientific and technical evidence proving our device is as safe and as effective as a legally marketed “predicate device.”
To achieve this, the FDA scrutinizes every aspect of the product, tra cui:
Engineering & Progetto: Detailed schematics and specifications.
Biocompatibility Testing: Ensuring all materials in contact with the skin are non-toxic and non-irritating.
Performance Data: Rigorous testing for light energy output, wavelength accuracy, electrical safety, and electromagnetic compatibility (EMC).
Comprehensive Risk Management: A full analysis and mitigation of any potential risks.
Labeling & User Manuals: Ensuring all claims are accurate and instructions are crystal clear for the end-user.
This is not a simple registration. It is an exhaustive review that confirms a device meets the highest standards of medical-grade performance and safety.
Your Strategic Partner for Growth
Receiving FDA 510(k) clearance is a defining moment for Wakelife, but more importantly, it is a direct fulfillment of our promise to you, our partners. It solidifies our role not just as a manufacturer, but as a strategic ally dedicated to providing globally compliant, sicuro, and effective beauty solutions that drive market growth.
We build devices that build brands. Now, we do so with the official backing of the world’s most respected regulatory body.
Ready to elevate your brand with an FDA-cleared, market-proven hero product?
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