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Anti-Acne Light Therapy Mask
Instructions for Use
Welcome to illuMask.
This revolutionary device brings acne light therapy into your own home. Therapeutic blue and red light
treat acne by targeting the bacteria that cause acne. The secret to clear skin is to treat the whole face to
prevent breakouts before they begin. Using the illuMask Anti-Acne Light Therapy Mask for 15 minutes
every day will dramatically reduce the presence of acne and help control future breakouts before they get
started.
Use illuMask once a day.
illuMask will turn off automatically at the end of each 15 minute session and will last for 30 treatments.
Welcome to a new you.
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illuMask.com
Table of contents
Getting to know illuMask
How illuMask works
How to use illuMask
Who should use illuMask
Warnings
Precautions
Risks
Interpreted summary of clinical data
Benefits
Storage & Care
Troubleshooting
Warranty
Glossary
Page 4
Page 5
Page 6-7
Pages 8-9
Page 10
Page 11
Pages 12-13
Page 14
Page 15
Page 16
Page 17
Page 18
Page 19
Instructions for use
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Getting to know illuMask
Over-ear arms
Mask face
Lights
Eye Shield
Treatment Counter
Nose piece
Power Button
Controller
Power Cord
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Front
Back
How illuMask works
Acne starts with the build up of oil
under the skin which causes a type
of bacteria called P. acnes to multiply.
Pores get blocked with this bacteria,
excess oil, and dead skin cells. The
result is an acne breakout.
See for yourself how illuMask works!
Blue and red light therapy treats acne
by targeting the bacteria in the skin
that causes acne breakouts. The light
gently penetrates the skin to kill the
bacteria. When you reduce bacteria,
you reduce acne breakouts1,2.
Goldberg, DJ, and Russell BA: “Combination Blue (415 Nm) and Red (633 Nm) LED Phototherapy in the Treatment of Mild to Severe Acne Vulgaris.” Journal of
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Cosmetic and Laser Therapy. 2006 8: 71-75
Lee SY, You CE, and Park MY; “Blue and Red Light Combination LED Phototherapy for Acne Vulgaris in Patients with Skin Prototype IV.“ Lasers in Surgery and
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Medicine. 2007; 39: 180-188
Instructions for use
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How to use illuMask
1 sec.
1. On your first time using illuMask,
the session counter will show 30
sessions left on the device.
Your illuMask will last for 30
fifteen-minute sessions.
2. Wash and dry your face prior
1 sec.
to treatment
to remove oil and
makeup.
15 min.
1 sec.
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1 sec.3.
sec. over-ear arms and put
Open 1the
on illuMask like you would a pair of
glasses.
For the most consistent results with illuMask, use it to complement your regular skin care routine and do
not skip sessions.
4. Press and hold the power button
for 1 second to begin your treatment.
Relax with illuMask in place for the
next 15 minutes. You can either close
your eyes or keep them open during
the session, whichever way feels
comfortable for you.
5. illuMask will turn off automatically 6. After each session the
after 15 minutes. If you need to
counter will show how many
turn illuMask off during treatment,
sessions remain.
press and hold the power button for
1 second. Note that doing so will
decrease the remaining number of
sessions by one.
1 sec.
15 min.
1 sec.
1 sec.
15 min.
Instructions for use
7
Who should use illuMask
Use this chart1 to determine if illuMask Anti-Acne Light Therapy Mask is right for you.
Indications for use: illuMask is intended to emit energy in the red and blue region of the spectrum, specifically
indicated to treat mild to moderate acne on the face.
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Acne Type
Should you use illuMask?
Description
Clear Skin
No
No acne
Mild Acne
Yes
Up to some blackheads and
whiteheads, a few pimples and
pustules, no nodules
illuMask.com
Example
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Acne Type
Should you use illuMask?
Description
Moderate Acne
Yes
Up to many blackheads and
whiteheads, some pimples and
pustules, only a few small nodules.
Severe Acne
No. This product is not
recommended for severe
acne as the benefits have
not been established.
Up to many blackheads, whiteheads,
pimples and pustules, some nodules
Example
Acne assessment criteria is based off of the FDA Proposed Acne Scale for Baseline Assessment.
“US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for Industry; Acne
Vulgaris: Developing Drugs for Treatment (2005).”
Instructions for use
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Warnings
It is not recommended to use illumask if you are pregnant, may be pregnant, or nursing, as the device was
not tested on pregnant or nursing women.
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Precautions
Do not get water or liquid inside any part of the device as it may cause the device to not turn on.
This device is limited to use by a single person. Do not share the device with other persons.
If you experience any discomfort from illuMask, stop using the device.
Instructions for use
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Risks
Event: Correct use: 35 of 35 subjects made no error using device*
Hazard
How often subjects
had the hazard
Harm
How often this hazard
harmed them
No known hazard from
correct use of the
illuMask device
Not applicable
Not applicable
Not applicable
Event: Incorrect use: 0 of 35 subjects made at least one error using device**
Hazard
How often subjects
had the hazard
Harm
Device was shared with
another person
0 out of 35 subjects
Possible crosscontamination
0 out of 35 subjects
Did not remember or
comprehend instructions
and warnings about use
while pregnant or nursing
0 out of 35 subjects
Unknown, unreported,
unobserved
0 out of 35 subjects
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How often this hazard
harmed them
Hazard
How often subjects
had the hazard
Harm
How often this hazard
harmed them
Did not remember or
understand instructions
and warnings
0 out of 35 subjects
Unknown, unreported,
unobserved
0 out of 35 subjects
Water or liquid got inside
the device
0 out of 35 subjects
Device may not turn on
0 out of 35 subjects
*Correct use: Doing all things and steps exactly like the user manual directs.
**Incorrect use: Failing to follow the instructions for use given in the manual provided with illuMask device.
Reasons for incorrect use include, but are not limited to, not understanding information and/or choosing to not
follow instructions one does understand.
Note: The data provided in the above risk tables was obtained from the Usability Study conducted in May 2013.
This data is representative of the potential risks that may occur. Only the known risks are listed. However, the
device is a minimal risk device when used in accordance with the instruction manual accompanying the device.
Although the illuMask Anti-Acne Light Therapy Mask has been shown to be safe in the clinical study (see following
page for details), there may be unforeseeable risks that have not been identified at this time. The possibility of
risks that may occur with the use of light therapy include:
1. Mild reddening of the skin
2. Mild tingling sensations
Instructions for use
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Interpreted Summary of Clinical Data
An 8-week clinical study was conducted by a leading physician to evaluate the illuMask in treating acne
breakouts. 30 patients were enrolled in the study, of which 27 completed the full 8-week treatment period.
3 patients did not complete the study due to reasons outside of the clinical study. No adverse events were
reported or observed during the clinical study.
All patients received a supply of a mild face wash and illuMask devices to use at home. Patients used
illuMask once daily. No other acne treatment products were used. Patients visited the physician’s office
for follow-up visits at Baseline, Week 2, Week 4 and Week 8. Both physician assessment and patient selfassessment data was collected at each visit. A summary of results of the clinical study can be found on the
following page titled “Benefits”.
For more information about the clinical study, visit illuMask.com
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Benefits
The benefits as demonstrated in the 8-week clinical trial were:
•
•
•
82.8% average decrease in the number of inflammatory acne lesions
71.2% average decrease in the number of non-inflammatory acne lesions
47.7% average decrease in the appearance of redness associated with acne breakouts
•
The Overall Acne Severity Assessment Score, which is based on the FDA guideline for grading acne
severity, exhibited a median improvement of 2 points. At the Baseline visit, patients exhibited a median
grade of “4 - Moderate Acne” and at the final Week 8 visit, they exhibited a lowered median grade of
“2 - Almost Clear Skin.”
Instructions for use
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Storage & Care
Cleaning
Clean the eye shield frame or outside
of illuMask whenever it appears
dirty. Moisten a soft cloth with water
or isopropyl alcohol and lightly wipe
down the device. Do not get water or
liquid inside any part of the device.
Maintenance
illuMask does not need regular or
special maintenance.
Storage
No special storage is needed.
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Travel
If traveling with illuMask, pack the
device in its original packaging to
prevent damage.
Life of the Device
illuMask is designed to work for 30
sessions. Dispose of properly after
session counter reaches zero.
Disposal (4 AA batteries included)
Please follow your local regulations
where you live for proper disposal of
battery operated devices. Dispose of
batteries by removing the screws on
the back of the controller.
Troubleshooting
Problem
Possible Cause
Action Required
Unit will not function
‘On’ power button was not pressed
‘On’ button should be pressed and is
located on the controller
All 30 sessions have been used
If the counter reads “0” there are no
more sessions left and it will be time to
purchase a new illuMask
Mask does not fit
Over-ear arms have not been
extended properly
Use over-ear arms and nosepiece to
position the mask for a comfortable fit
Light flickers during session
Battery power intermittent
Check that the power cord is in good
condition. If the problem persists, contact
La Lumiere Customer Care
If you have any unresolved problems, please call Customer Care at 1 (866)-331-5444 for assistance.
Instructions for use
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Warranty
If you are not fully satisfied with illuMask after 15 treatments, you may return the item within 30 days of purchase
date for a full refund. Any taxes, shipping & handling, and other charges are non-refundable. The item must be
returned in good condition, with all original packaging and the original receipt to receive full credit. The counter
must show at least 15 treatments remaining.
Send to:
La Lumiere, LLC
7120 Krick Rd.
Cleveland, OH 44146
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Glossary
Bacteria
Propionibacterium
acnes (P. acnes) that
causes acne breakouts.
It lives on oil secreted by
the skin.
Blackhead
A small bump on the
skin with a black center,
not inflamed.
Inflamed
Red and sensitive to the
touch.
Pimple
A red and sensitive
(inflamed) bump on the
skin.
Pustule
A red and sensitive
(inflamed) bump on the
skin with a white or yellow
center.
Whitehead
A small bump on the skin
with a white center, not
inflamed.
Nodule
An inflamed mass, like
a knot, either raised or
felt under the skin.
Instructions for use
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Customer Care
1 (866) 331-5444
[email protected]
illuMask.com
Patent Pending
Manufactured for
La Lumiere, LLC
7120 Krick Rd.
Cleveland, OH 44146
©2012 La Lumiere, LLC All rights reserved.
illuMask and the illuMask logo are trademarks of La Lumiere, LLC
Shelf Life:
3 years from
Date Code on Controller
Designed in NYC
Made in China
Version 1.02