HairMax LaserComb Lux 9, LaserComb Professional 12 User Manual

USER MANUAL

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HairMax Lux 9 & Professional 12

The HairMax LaserComb has helped hundreds of thousands of people
combat their hair loss and grow beautiful hair. Now, Lexington is proud
to introduce the next generation of the revolutionary HairMax
LaserComb®.

Introducing the New HairMax Lux 9 and Professional 12

Using advanced laser technology, the Lux 9 and Professional 12
provide safe and nourishing laser light energy to weakened hair
follicles. The laser light energy stimulates the hair follicle, promoting
new hair regrowth and producing healthier, more beautiful hair. The
new Lux 9 and Professional 12 provide safe and effective at-home
treatment as the original HairMax, but now are cordless. The new Lux
9 and Professional 12 feature a sleek ergonomic design with a
rechargeable lithium ion battery to give you the freedom of
movement as you treat your thinning hair.

The new HairMax Lux 9 and Professional
12 utilize the patented hair parting teeth
mechanism. Remember, the laser
treatments are only effective when the
laser reaches the scalp. The teeth part
the hair, moving it aside, to allow the
maximum amount of laser energy to
reach the scalp and energize the
weakened hair follicles.

Like brushing your teeth to maintain healthy teeth & gums, regular
HairMax usage is recommended. Use the HairMax three times a week
on non-consecutive days for about 8 -11 minutes a session (eight
minutes for Professional 12 and eleven minutes for Lux 9). Over the
first few months, you may notice a gradual increase in the number of
hairs in a specific location. Most users realize on-going improvements
as they continue to use the HairMax. If you stop treating your scalp
with the HairMax, your hair may regress back to its previous state.

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To view our safety and usage videos, visit

www.internationalhairmax.com/videos

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ABOUT LEXINGTON INTERNATIONAL

Lexington International, LLC is a leader in hair growth, hair
care and hair science. The technology behind the HairMax
LaserComb is a result of 20+ years in Research &
Development in Sydney, Australia. Our primary objective is
to help those suffering from Androgenetic Alopecia. The
goal is to provide an effective treatment that is affordable,
easy to use and provides noticeable results without
adverse side effects. Lexington bases its success on the
number of people whose lives are enriched. We truly care

about conducting our business ethically and appropriately.
Because of this, Lexington complies with the FDA’s Good
Manufacturing Practices, is ISO 9001 & 13485 certified in quality
standards and our products meet CE requirements for safety.
Lexington’s products are also Patented and Trademarked across the
world.

BENEFITS

The HairMax LaserComb is a home-use Low-Level Laser PhotoTherapy
device to treat hair loss (Androgenetic Alopecia) and promote hair
growth. Laser PhotoTherapy process bathes the hair and scalp in laser
light to energize weakened hair follicles. In addition to new hair

growth and reduction in shedding, many users also routinely report
normalization of scalp conditions, increased body, shine and
manageability of their hair.

Individual results may vary. Over time, most users continue to see an
improvement of their hair and scalp conditions. If you stop using the
HairMax your hair may regress back to its original state.

More reasons why HairMax users are satisfied with HairMax:

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Real Results within just weeks
Thicker, Fuller, Healthier Hair
Improved Hair Condition
Convenient Home Treatment
Certified, Completely Safe
High User satisfaction

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CLINICAL DATA

The results of the key clinical study performed with the HairMax LaserComb
led to US FDA Clearance to market in January 2007. This was considered a
landmark event in the treatment of Androgenetic Alopecia. These clinical
results were published in

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“HairMax LaserComb

Phototherapy Device in the Treatment of Male Androgenetic Alopecia*”.

Study Objectives

The study was conducted to support the FDA 510(k) submission and was
subjected to an Investigational Review Board (IRB) approval and conducted in
accordance with GCP (Good Clinical Practices). The objectives of the study
were to assess the following:

- Promotion of hair growth through changes in hair density

- Cessation of hair loss

- Overall scalp health

- Safety

Study Design

The study was designed as a multi-centered, double- blinded, randomized
sham-device controlled trial conducted at four sites in the United States.
Subjects were instructed to use the laser hair growth treatment device three
times per week on non-consecutive days, for a total of 26 weeks. Hair
density measurements were performed at baseline, immediately prior to
randomization and again at 26 weeks.

Subject Population and Demographics

The study population included males between the ages of 30 and 60 years
with a diagnosis of Androgenetic Alopecia who had been experiencing active
hair loss within the last 12 months. The inclusion criteria required a Norwood­Hamilton Classification of IIa to V and Fitzpatrick Skin Type Classification of I
to IV.

Clinical Results

Subjects in the HairMax LaserComb® laser hair treatment group had
significantly greater increase in mean terminal hair density than subjects in
the sham group (p<0.0001). Subjects in the HairMax LaserComb® group also
had significantly better subjective assessments of overall hair growth than
subjects in the sham group (p=0.010). No subject experienced a serious
adverse event from the laser hair loss treatment and the adverse event
profiles were similar between the two treatment groups.
*Clin Drug Invest 2009: 29 (5): 283-292

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WARNINGS AND PRECAUTIONS

WARNING: Only use the HairMax according to the instructions

provided. Any other use is not recommended.

WARNING: Basic safety precautions should be observed when using this,
or any other electrical device. Do not allow children to use or play with
the HairMax. Keep out of reach of children. It is not a toy.

WARNING: Laser Light - Avoid Direct Eye Exposure. Do not point laser or allow
laser light to be directed or reflected toward other people. Never use
magnifying optical instruments with the HairMax. Do not stare directly at the
laser light or its reflection off a mirror-like surface. Doing so can cause
temporary irritation to your eyes. Prolonged direct exposure can harm your eyes.

CAUTION: If you are taking any photosensitizing medications or receiving
any therapy that sensitizes the skin to light, use caution when using the
HairMax. Please consult your physician if you have any other concerns.

CAUTION: Never use acetone or other solvents on any part of the HairMax.
Use of solvents on the window can block the laser light from coming
through.

CAUTION: Never use the HairMax if the cord or plug is damaged. Do not
put strain on the cord. If any malfunction occurs, do not attempt to repair
the HairMax yourself. This appliance has no user-serviceable parts and is
not to be opened or modified by the user. Use the HairMax only for its
intended use as described in this manual. Contact Lexington International
LLC for repairs at 561.417.0200.

The following laser safety label can be found on this product:

Wavelength: 650 nm

visible red light
This Laser Product is designated as Class 3R during
all procedures of operation.
Note: HairMax LaserComb has
no user-serviceable parts.
Location: On the underside of the handle
Model version varies

Accessible

Laser

Parameters

Wavelength 650 nm
Laser Power for classification <5mW CW
Beam Diameter <5 mm
Divergence 57 mrad
Number of lasers 9, 12

LASER LIGHT

AVOID DIRECT EYE EXPOSURE

CLASS 3R LASER PRODUCT

650nm, <5mW CW

CLASSIFIEDPERIEC 60825-1,

Ed 2, 2007-03

Manufactured By:
Lexington International LLC
2901 Clint Moore Road #260
Boca Raton, FL 33496 USA
Model: HM1 V6.02
Serial No:

Complies with FDA performancestandards for
laser products except for deviations pursuant

to Laser Notice No. 50, dated June24,2007

5VDC @.55 amps power supply

Laser Aperture

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561.314.2430

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.com

LASERLIGHT

AVOIDDIRECT EYE EXPOSURE

CLASS3R LASER PRODUCT

650nm,<5mW CW

CLASSIFIEDPER IEC 60825-1,

Ed2, 2007-03

ManufacturedBy:

LexingtonInternational LLC

2901Clint MooreRoad #260

BocaRaton, FL33496 USA

Model: HM1V6.02

SerialNo:

ComplieswithFDAperformancestandardsfor

laserproducts exceptfor deviationspursuant

toLaser NoticeNo. 50,dated June24, 2007

5VDC @.55amps powersupply

LaserAperture

SIDE VIEW HOUSING

TOP VIEW HOUSING

BOTTOM VIEW HOUSING

(g) TEETH

PARTS:
(a) BATTERY INDICATOR - Yellow during charging. Green is fully charged.
(b) INFORMATION DISPLAY - Laser ON, Battery Level, Usage Time.
(c) POWER BUTTON with GREEN light indicator - Turns on power.
(d) LASER BUTTON with RED light indicator - Turns on laser (POWER button must be pressed first).

*Caution - Use only as directed. Any variation of controls, adjustments, performance or procedures,

other than those specified, may result in hazardous exposure to laser light.
(e) SAFETY LABEL (removable) - “PLEASE REFER TO OUR USER MANUAL BEFORE USING THIS PRODUCT.”
(f) POWER CORD - International. 110-240VAC.
(g) TEETH - removable for cleaning
(h) LASER WINDOW - Do not look into laser window when laser is turned on. See CAUTIONS
(i) RESET KEY FUNCTION - to reset HairMax.
(j) LASER WARNING LABEL - contains SERIAL NUMBER - not removable.
(k) CHARGING CRADLE (STAND) - Stores and charges HairMax.
(l) CHARGING CRADLE INDICATOR - RED during charging, GREEN is fully charged.

(d) LASER BUTTON*

(c) POWER BUTTON

(a) BATTERY INDICATOR (b) INFORMATION DISPLAY

(i) RESET KEY FUNCTION

(g) TEETH (h) LASER WINDOW (j) LASER WARNING LABEL

(e) SAFETY LABEL

(f) POWER CORD

(f) POWER CORD

(f) POWER CORD

(l) CHARGING CRADLE
INDICATOR

(k) CHARGING CRADLE (STAND)

HAIRMAX Lux 9 & Professional 12 - PARTS

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