Wellness | Devices > Clearance and Certification

CLEARANCE

All of our wellness devices are officially registered and listed in the FDA’s database demonstrating compliance with FDA requirements and/or have received or expected to receive FDA 510(k) clearance.

We innovate our products using the same manufacturer, with the same quality, safety, and performance, standards, and depending on the product, medical-grade standards. Our devices are confirmed to be as safe and effective. While our devices are substantially equivalent to other legally marketed light therapy devices and have been evaluated for both effectiveness and safety, they are not intended to replace professional dermatological or other medical/paramedical care. Individual results may vary when using these devices. We strongly recommend speaking to your healthcare provider and reading the user guide carefully.

In the future, we may launch similar products as we expand our wellness line, and in some cases, those devices may be classified as "FDA Class I", which means they meet FDA requirements through registration and listing without needing 510(k) clearance, but will still fall in the same family of our product family.

Here’s a simple breakdown of where our Wellness products stand today:

Light Therapy Mask (Model E49)
SKU: NLEDK00-1TFM

• The Light Therapy Mask labeled “Model E49” is covered under FDA 510(k) clearance K243555. While the FDA listing may not explicitly name every internal variant (such as E49B or E49C), these are all iterations of the same cleared device. The mask is approved for over-the-counter use as a light therapy device for various skin-related concerns such as acne, fine lines, and uneven skin tone and is medical grade.

• The mask is FDA 510(k)-cleared and listed in the FDA’s Database. 🔗FDA 510(k) Clearance #: K243555. 

💡To verify, you can visit the FDA 510(k) database and search “E49” under Device Name. This will direct you to the appropriate clearance listing under the same product family (but it's conveniently linked for you above!)

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Wand (Model E356) & Grid Lamp (Model E82B)
SKU: NLRLTPK0801A203 | SKU: NLLTWDK0001A223 

• Our manufacturing partner and devices are officially registered and listed in the FDA’s database, demonstrating compliance with FDA requirements and ensures our products are tracked within the FDA’s regulatory framework. The device will be added to the FDA 510(k) listing once our request is approved.

💡To verify, you can visit the Establishment Registration & Device Listing and search “3017555752” under the field: Registration or FEI Number. Make sure to click the "Show all 27 Listings" to locate our devices. This will direct you to the appropriate listing under the same product family. We have added our name, "Nanoleaf" to these two (2) to ensure you are able to identify them with ease.

CERTIFICATION

Our wellness devices meet leading international standards. 

They are certified by the Federal Communications Commission (FCC) to comply with regulations for electronic safety and emissions, the Restriction of Hazardous Substances Directive (RoHS) to limit hazardous materials for environmentally friendly and safe design (a standard widely adopted in global markets), and Conformité Européenne (CE), which confirms compliance with health, safety, and environmental protection requirements recognized globally in other regions that align with these standards.

Whether it’s our Mask, Panel, or Wand, each product is designed and manufactured to meet these strict certifications, ensuring safe, reliable, and globally compliant use. We put the health and safety of our customers first and foremost.

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