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. | | | | |