PlasmaLite is an Fluorescent Pulse Light (FPL) device made in Sweden by Medical Bio care and marketed primarily in England at this time.
The Prolite FPL is the next generation of the Plasmalite. FDA approval has been acquired for hair removal in all skin types, skin rejuvenation, tattoo removal and vascular lesions.
On 8 January 2002, the US Food and Drug Administration found PlasmaLite (also called ProLite) to be substantially equivalent to the EpiLight/PhotoDerm device cleared in Docket K974536.
This decision in Docket K013366 found the system “is intended to remove unwanted hair for all skin types according to the Fitzpatrick Scale.”
The device is allowed to make claims in the US for permanent hair reduction, but they do not have clearance to make claims of permanent hair removal which are often found on British sites promoting the device.
American Medical Bio Care Inc.
1201 Dove Street
5th floor, Suite #520
Newport Beach, 92660 CA
U.S.A.
Ph: +1 949 477 5795
Fax: +1 949 477 5799
Clearance contact: CONNIE W HOY
PHONE NO : 530-666-7616
908 STETSON STREET SE WOODLAND, CA 95776
DECISION MADE: 08-JAN-02