Wellness | LED Face Mask > FDA 510(k)

🔗FDA 510(k) Clearance #: K243555

NOTE | Individual results may vary. Always follow usage guidelines and consult a healthcare provider if you have 
any underlying conditions.

The Nanoleaf Wellness LED Mask has received FDA 510(k) clearance under number K243555, confirming that the device meets medical-grade safety and performance standards as a Class II device.

This means it has been reviewed and 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.

This clearance demonstrates that the device is substantially equivalent to other legally marketed light therapy devices and has been evaluated for both effectiveness and safety. While it is FDA-cleared, it is not intended to replace professional dermatological care.

Is Model E49 FDA Cleared?

Absolutely! The LED 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 design.

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!)