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4

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

Peer

Reviewed

Journal

“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 Norwood-
Hamilton 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

Summary of Contents for LaserComb Advanced 7

Page 1: ...USER MANUAL...

Page 2: ...ies Now that the HairMax is bat tery powered it gives you the freedom of movement as you treat your thinning hair The new HairMax Advanced 7 utilizes Lexington s patented hair parting teeth mechanism...

Page 3: ...CE requirements for electrical and laser 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...

Page 4: ...cted 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 random...

Page 5: ...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 o...

Page 6: ...removable h CRADLE STAND optional not included d TEETH d TEETH f WINDOW e BATTERY COMPARTMENT SCREW c OPTIONAL POWER CORD not included c OPTIONAL POWER CORD not included c OPTIONAL POWER CORD not inc...

Page 7: ...ighten screw The HairMax Advanced 7 is designed to provide the optimum laser output even as the batteries age When the batteries weaken to the point where they will no longer power the lasers to their...

Page 8: ...HairMax as recommended is needed to maintain healthy hair If you stop using the HairMax your hair may regress back to its original state Studies conducted during 20 years of development of the HairMa...

Page 9: ...d The HairMax is now ready for use Note The HairMax will automatically vibrate every four 4 seconds This is an indication for the user to move the HairMax to the next portion of the scalp For turning...

Page 10: ...the lowest position If using the optional power cord remove the POWER CORD from wall electrical outlet and return the device to the CRADLE STAND for storage Illustr 6 VIBRATION TIMER The HairMax is m...

Page 11: ...keep the TEETH of the combs clean gently remove any hairs or dust with a slightly moistened towel For a more thorough cleaning gently pull out comb TEETH from the center TEETH can be washed using soap...

Page 12: ...any special indirect or consequential damages that are directly or indi rectly related to the use of or the inability to use the HairMax even if Lexington International LLC has been advised of the pos...

Page 13: ...se of an electrical outlet protected by a Ground Fault Circuit Interrupter is recommended Do not use the HairMax near heated surfaces Contacting a heated surface with the cord or plug can cause the pr...

Page 14: ...nt Device Failure Mode The laser light does not fade or diminish over time At the end of the laser s life or if it fails for any other reason no red light will shine out of the device Do not look dire...

Page 15: ...ert power cord into the HairMax Slide the POWER LASER BUTTON to the on position Try another wall electrical outlet My HairMax will not turn off Slide the POWWER SWITCH to the lowest OFF position If us...

Page 16: ...mber _______________________________________ Date of Purchase _____________________________________ Address ____________________________________________ _______________________________________________...

Page 17: ...5000 com com com tape or staple...

Page 18: ...ark of Lexington International Copyright 2009 Lexington International LLC All rights reserved LEX10001 01 11 09 To validate your warranty please return this completed warranty card or register online...

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