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FDA Reports

For informational and educational purposes only. Salon Lasers, Inc. does not represent or sell the MEP 90. Salon Lasers, Inc. does not attempt to draw any comparison to our products and the MEP 90 or the HairMax LaserComb.*

NEW Laser Hair Growth Stimulation System Receives FDA Clearance for Hair Loss in Women

MEP 90

As posted on the FDA website, the "MEP-90 Hair Growth Stimulation System" manufactured by Midwest RF LLC Hartland, WI received 510(k) clearance. The device is indicated for "The treatment of androgenetic alopecia in females by promoting hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fizpatrick Skin Typing of I to IV." The MEP-90 is the second FDA-cleared medical device indicated for the treatment of androgenetic alopecia. It is the only FDA-cleared device specifically for female hair loss patients.

Clinical Data:

• - An IRB pre-approved clinical trial with oversight was performed.
• - Each subject recieved a total of 36 20-minute treatments over 18 wks
• - Results were reviewed at 10-weeks (20 treatments) and 18-weeks (36 treatments) levels
• - After 20 treatments (10 weeks) 92% of subjects had increased hair counts of >+10% with 57% demonstrating an increase of 30%.
• - 98% of subjects indicated a medically-significant stabilization of rate of hair loss.
• - After 36 treatments , 97% of subjects had an increased hair count of >+ 20%. A total of 89% of all subjects demonstrated an increased hair count of >+30%, with 57% demonstrating an increased hair count of >+50%.

Read the full FDA 510(k) clearance on the FDA website: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K091496.pdf

The MEP-90 has approximately 90 laser diodes directed at the scalp delivering the low level laser therapy.

Article: Lasers useful for promoting hair growth. Publish date: Jun 1, 2010

By: Joely Kaufman, M.D., Bernard Nusbaum, M.D.

HairMax LaserComb

In January of 2007 the FDA cleared the first device in history to re-grow hair, the HairMax LaserComb .

The report stated:
• Effective on 93% of male subjects between 30-60 years of age
• Grew an average of 19 new hairs per centimeter
• Results were obtained in 6 months.

The HairMax LaserComb is an over-the-counter medical device intended to be sold to, and use by, the end consumer and can not be used to perform a service in a salon.

* This page is for informational purposes. Salon Lasers, Inc. does not sell the MEP-90 Hair Growth Stimulation System, nor does Salon Lasers, Inc. claim any connection to the product.

Pam Matheson, owner of the Bentley Salon in Hickory, North Carolina.

"Ever since I purchased the salon laser my clientele and revenue has gone up tremendously." (Read more)

"I can honestly say that this is the easiest product I have every sold, and that I am seeing good results on my clients, after only 3 months, which is very exciting for me and for my clients." (Read more)