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SUMMARY OF CLINICAL STUDY IN MEN

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Clinical studies were conducted at multiple locations in the United States. Participants in the study were 

males diagnosed with Androgenetic Alopecia, which includes hereditary hair loss, and had light to brown 

skin tones. Subjects were divided into two groups, LaserComb Group and a Control Group. The Control 

Device looked and sounded like the LaserComb device but did not include a laser light. The Clinical studies

adhered to all GCP (Good Clinical Practice) guidelines, were approved by an IRB (Institutional Review Board) and

listed on www.clinicaltrials.gov.

During the 6 month clinical study, subjects treated their hair once

per day, 3 times per week on non-consecutive days. The number of

thick, normal healthy hairs in the target zone were counted at week

1, week 16 and week 26.

Results at the 26 week visit showed that over 90% of the men 

saw an increase in hair counts (based on a minimum of 32 new 

hairs per square inch being observed at the follow up visit).

No subjects in the study experienced any serious adverse events. 

In fact, the number and types of adverse events were similar in 

the LaserComb and Control Groups.

Hair Count Change

In the clinical study, after 26 weeks of treatment with the

LaserComb devices versus the Control Device, the following

increases in hair count were found.

Summary of Contents for LaserComb Ultima 9

Page 1: ...ity and safety visit Hairmax com videos and Hairmax com QualitySafety For International Translations visit Hairmax com manual HairMax Customer Service Phone 1 866 527 3726 1 561 417 0200 Email info ha...

Page 2: ...Ultima 9 Ultima 12...

Page 3: ...Parts 9 Getting Started 10 Charging Options 10 Proper Use 11 Treatment Instructions 12 What your HairMax Ultima 9 and 12 comes with 14 Troubleshooting 15 Other Useful Information Safety Label 16 Powe...

Page 4: ...an unobstructed path to the scalp The LaserComb has teeth that part the hair and allow the maximum amount of laser energy to reach the scalp Treatment with HairMax LaserComb The LaserComb should be u...

Page 5: ...hereditary condition Doctors use a system known as the Norwood Hamilton Classification men and the Ludwig Savin Classification women to describe the degree of hair loss Below are the pictures of the...

Page 6: ...usually burns with sun exposure fair often in people with red or blond hair and blue green or hazel eyes Type 3 White or olive skin tone sometimes burns with sun exposure fair seen in people with any...

Page 7: ...ons or products that make you sensitive to light you should test the LaserComb to make sure you do not have a reaction Some of the things that can cause increased sensitivity to the LaserComb could be...

Page 8: ...ngton s Customer Service toll free at 1 866 527 3726 Testing the LaserComb for sensitivity Before beginning treatment be sure to test the HairMax LaserComb for sensitivity Turn the device on hold the...

Page 9: ...l free at 1 866 527 3726 for repair or replacement Device Failure Mode The HairMax LaserComb is designed to last for 10 15 years of regular use The laser light does not fade or diminish over time At t...

Page 10: ...ew Board and listed on www clinicaltrials gov During the 6 month clinical study subjects treated their hair once per day 3 times per week on non consecutive days The number of thick normal healthy hai...

Page 11: ...ed by an IRB Institutional Review Board and listed on www clinicaltrials gov During the 6 month study subjects treated their hair once per day 3 times per week on non consecutive days The number of th...

Page 12: ...ASER BUTTON INFORMATION DISPLAY POWER CORD SAFETY LABEL TEETH LASER WINDOW WARNING LABEL CHARGING CRADLE STAND HAIRMAX LASERCOMB PARTS LaserComb Ultima 9 and 12 are identical models that vary only in...

Page 13: ...9 and 12 models come with a rechargeable battery permanently installed Read this manual completely before you start to use your LaserComb Use the LaserComb Ultima 9 for 11 minutes per treatment and L...

Page 14: ...ith one of the charging options as described on page 10 GETTING STARTED PROPER USE GETTING STARTED PROPER USE 11 Proper Use The LaserComb Ultima 9 should be used for 11 minutes and LaserComb Ultima 12...

Page 15: ...rComb for 4 minutes and 45 seconds Treatment Instructions Before beginning treatment be sure to test the HairMax LaserComb for sensitivity Page 5 After you have turned on the LaserComb place it flat o...

Page 16: ...ir of comb teeth that part the hair so the light can more effectively reach the scalp You will make a few complete passes over your scalp within recommended treatment time When the LaserComb is on it...

Page 17: ...aserComb very slowly Remember you are bathing the scalp with laser light If you move it too fast the treatment will not achieve the optimal results to promote hair growth Total time required for treat...

Page 18: ...outlet If your LaserComb will not turn off Press and hold power button for 4 seconds If using power cord unplug the LaserComb and press power button for 4 seconds If your LaserComb beeps vibrates irr...

Page 19: ...the underside of the handle Model version varies UL9 V01 UL90010000 LEXLBL UL9 10 14 UL90010000 Power Supply Specifications Output 6VDC 1 0A Plug 9mm x 3 5mm center positive The power supply for the...

Page 20: ...th a slightly moistened towel Don t use any acetone soap or detergents only warm water To clean the teeth more thoroughly slide the teeth towards the top of the LaserComb and gently pull out Clean wit...

Page 21: ...rComb in a fire or store in high temperatures greater than 140 F 60 C This symbol on the product or on its packaging indicates that this product must not be disposed of with your other household waste...

Page 22: ...ease refer to the User Manual for complete warranty terms We guarantee your satisfaction To validate your warranty card register online at www hairmax com warranty or complete and mail this warranty c...

Page 23: ...Return address Place stamp here Lexington International LLC 777 Yamato Road Suite 105 Boca Raton FL 33431 Staple or tape here...

Page 24: ...or ConsequenTiAL DAMAGes THAT Are DireCTLy or inDireCTLy reLATeD To THe use oF or THe inAbiLiTy To use THe HAirMAx LAserCoMb even iF LexinGTon inTernATionAL LLC HAs been ADviseD oF THe PossibiLiTy oF...

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