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FDA Clearance and Patents list  
 

FDA Clearance
Ultrapeel® (dms1000)
510(K) Number K965252

Patents
Advanced Microdermabrasion and Transdermal Delivery Systems with Patented Technology
The following patent numbers have been issued to Mattioli Engineering:

  • 5,810,842 - Equipment for microdermabrasion through a flow of an air reducing substance mix
  • 5,954,730 - Mixing bottle for dermabrasion treatment and method of using
  • 6,039,745 - Equipment for microdermabrasion through a flow of air reducing substances mix and relative hand piece
  • 6,120,512 - Dermabrasion apparatus having disposable sterilized components
  • 6,149,634 - Collecting bottle for dermabrasion treatment
  • 6,368,333 - V-shaped hand piece for dermabrasion
  • 6,306,147 - Dermabrasion by a flow of reducing substances and having disposable sterilized components
  • 6,322,568 - Dermabrasion by a flow of reducing substances and having disposable sterilized components
  • 20020107529 - Dermabrasion apparatus and method having oval-shaped mixing bottle
The United States Food and Drug Administration (FDA) cleared the Ultrapeel® Microdermabrasion Systems for sale in the United States on December 9,1996 and the Transderm Ionto System in December 2003. The additional vibration feature was cleared in October 2004.
The following studies have been conducted in association with the FDA clearance and according to FDA requirements:
  • Dermal Toxicity performed by Biocon, Inc. - Rockville, MD
  • Medical reports prepared by Dr. L. Marini, Dr. R. LoBrutto, Dr. A. Canella, and Dr. S.Rosato
  • University of Florence studies on Lidocaine delivery
In addition, Mattioli Engineering has been inspected and is compliant with GMP standards. The Ultrapeel® Microdermabrasion Systems are CE marked.
 
 
 
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