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

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 rec'd a total of 36 20-minute treatments over 18 wks

- Results were reviewed at 10-wk (20 tx's) and 18-wk (36 tx's) levels

- After 20 tx's (10 wks) 92% of subjects had increased hair counts of ³10% with 57% demonstrating >+ increase of 30%.  98% of subjects indicated a medically-significant stabilization of rate of hair loss.

- After 36th tx's, 97% of subjects had an increased hair count of ³20%.  A total of 89% of all subjects demonstrated an increased hair count of ³30%, with 57% demonstrating an increased hair count of ³50%.

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 diodes which rotates around the scalp delivering the low level laser therapy.

For more information on Low Level Laser Therapy and Hair Loss/Hair Growth for women, please visit our Female Hair Loss information section at http://www.baumanmedical.com.  Bauman Medical Group has the only in-office laser therapy 'spa' in Florida specifically designed for hair loss patients.

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