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3. Device description
1. Flexible silicone CLEAR device with integrated eye-wear
2. Controller (containing a lithium battery) & power supply
3. Country specific adapters
4. 2x adjustable straps
5. Carry bag
No pimples or spots or
yellow pus-filled spots.
No whiteheads or
blackheads
Clear Skin
NO
Omnilux CLEAR is NOT
indicated for clear skin.
Omnilux CLEAR should
NOT be used to prevent
pimples or spots forming.
2. Who should use Omnilux CLEAR?
The typical appearance of acne is a mixture of the following: greasy
skin, red pimples or spots, yellow pus-filled spots and scars. Use
this chart to determine whether Omnilux CLEAR is suitable for you.
Acne Type Description
Suitable for
Omnilux CLEAR
A few pimples or spots, a
few pus-filled spots,
some whiteheads or
blackheads
Mild Acne
YES
Mild acne is suitable for
treatment with Omnilux
CLEAR
Some pimples or spots,
some pus-filled spots, only
a few small nodules. Some
whiteheads or blackheads
Moderate
Acne
YES
Moderate acne is suitable
for treatment with
Omnilux CLEAR
Many pimples or spots,
many pus-filled spots.
many nodules
Severe
Acne
NO
Omnilux CLEAR is NOT
indicated for severe acne.
Please consult your
doctor for a more
appropriate treatment.
Many whiteheads or
blackheads. No pimples
or spots. No pus-filled
spots
Whiteheads
or
Blackheads
or
Comedonal
Acne
NO
Omnilux CLEAR is NOT
indicated for whiteheads or
blackheads. Please consult
your doctor for a more
appropriate treatment.
To find out if Omnilux CLEAR is right for you and to
find a full list of who can and who can’t use the
Omnilux CLEAR, scan the QR code.
Omnilux CLEAR is a home-use wearable LED light therapy device. It produces
a cool, narrow band of light which reduces mild to moderate acne vulgaris on
the face. It consists of a flexible silicone device that contains light emitting
diodes (LEDs) and a controller. The LEDs generate the light. The device is
worn on the face and is held in place by adjustable Velcro straps. The
controller turns the LEDs ON/OFF and controls power to the mask. The
controller contains a rechargeable lithium-ion polymer battery and uses a
visible display comprising of 3 micro LEDs to show the user the battery charge
status of the device. The power supply is used to charge the lithium battery
and is connected to a suitable mains outlet via a 2 or 3 pin input socket and
wall plug. The power cable is connected to the controller by a standard micro
USB A-C connector.
Omnilux CLEAR cannot be operated while charging.
The device is not used to make measurements of any sort, or to draw any
conclusions regarding the indication to treat. The device does not require
checks on the light output as the LEDs do not dim with age to any practical
extent.
3.1. Intended use
Omnilux CLEAR is an over-the-counter LED device that emits energy in the
red and blue region of the light spectrum, and is specifically indicated to
treat mild to moderate acne vulgaris on the face through a non-thermal
mechanism called endogenous Photodynamic Therapy.
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