FDA Controlled Study Results:

MEP-90 Laser Hair Growth System

To gain FDA clearance of the MEP-90 used by HRI of DFW, a comprehensive clinical test was completed at the Koher Center for Hair Restoration, with Institutional Review Board (IRB) preapproval and oversight. Each subject tested during the MEP-90 efficacy determination received a total of 36 treatments. The 20-minute treatments occurred over a period of 18 weeks.

Our exclusive MEP-90 Laser Hair Therapy System has received FDA 510(K) clearance (Approved #K091496) for women with female pattern thinning (androgenetic alopecia). These non-surgical hair loss treatments are NOW available by prescription only, under a doctor’s supervision and only at Hair Restoration Institute of DFW in the Fort Worth area.

Results of FDA Study:

  • After 20 treatments (Phase 1)
  • 92% of the patients presented an increase hair count of at least a minimum of 10% with 60% having an increase of a minimum of 30% increase in hair.
  • Phase 2: (After 36 treatments)
  • 96% of patients presented an increase hair count of at least 20% with 88% having an increase minimum of 30% more hair.
  • Phase 3: (After 52 treatments)
  • An astounding 97% of patients presented an increase hair count of a minimum of 20% with 77% having a minimum increase of 51% more hair.

Clinical Data:

  • An IRB pre-approved clinical trial with oversight was performed.
  • Each subject received 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



Whether you are experiencing thinning hair and want to stop your hair loss, or want more hair, we offer the latest clinically proven hair loss treatment and hair restoration solutions for men and women of all ages and hair types.

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