LUMI Clear™ FDA-Cleared LED Light Therapy Mask

Overview

LUMI Clear™ is an over-the-counter LED silicone mask that is FDA-cleared under 510(k) K233114. It is cleared to treat mild to moderate acne vulgaris of the face (blue 415 nm light) and to treat wrinkles (red 630 nm and near-infrared 830 nm light).

The soft silicone mask contours to the face and is worn for about ten minutes at a time, with a rechargeable controller and adjustable head straps.

Key features

• FDA 510(k) cleared: K233114
• Anti-acne mode: blue 415 nm light for mild to moderate acne vulgaris of the face
• Anti-wrinkle mode: red 630 nm and near-infrared 830 nm light
• Flexible silicone mask with adjustable head straps
• Rechargeable controller, eye shields and USB charging cable included

Best for

• Mild to moderate acne on the face
• Facial wrinkles
• A daily or near-daily at-home skincare routine

Specifications

How to use

1. Start with clean, dry skin.
2. Put the mask on and adjust the straps. Use the supplied eye shields.
3. Turn on the controller and choose the acne or wrinkle mode.
4. Use about 10 minutes per session, 3 to 5 times per week, as shown in the manual.

Safety and precautions

• Protect your eyes. Do not look directly into the LEDs. Use the eye protection that comes with your device, or keep your eyes closed, when treating the face or scalp.
• Check with your clinician first if you are pregnant, have a history of seizures triggered by light, have cancer or an active skin condition in the treatment area, or take medication that makes you sensitive to light.
• Do not use over open wounds or on skin with active infection.
• Stop using the device if you feel heat, pain or irritation.
• Not waterproof. Keep away from water and do not use in the bath or shower.
• Keep out of reach of children. Not a toy.
• Use the supplied eye shields.
• Stop and ask your clinician if you develop a rash or irritation.

What's in the box

• LUMI Clear LED mask
• Adjustable head straps
• Rechargeable controller
• USB charging cable
• Protective eye shields
• User manual

Warranty, shipping and returns

1-year limited warranty. From the date of delivery, we repair or replace your device at no cost for the first 3 months. From month 4 through month 12 we provide replacement parts and repair support at no cost. The warranty does not cover damage from misuse or improper storage, repairs or disassembly not authorized by us, shipping damage or events outside our control, or units not purchased from Helio Aesthetics. Paid service is available after the warranty period.

See our Shipping Policy and Returns & Warranty policy for delivery times, returns and how to make a claim.

Frequently asked questions

Is it FDA approved?
It is FDA-cleared (510(k) K233114). FDA clearance is not the same as FDA approval.

What is it cleared to treat?
Mild to moderate acne vulgaris of the face and wrinkles.

Can I use it on my neck?
The clearance covers the face. Follow the manual and do not use it for other areas.

LUMI Clear is an FDA-cleared over-the-counter device (510(k) K233114) for the indications listed above. FDA clearance is not FDA approval. Results vary and consistent use is needed. Ask your clinician before use if you have a skin condition or take medication that makes you sensitive to light.