PhotoMedex, Inc. - June 16, 2015
Issue Date
Jun 16, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Gioria Fishman
Contact Title
Executive Vice President
Address 1
2375 Camino Vida Roble
Address 2
Ste. B
City
Carlsbad
State
CA
Zip/Postal Code
92001-1556
Country
United States
Inspection Range
May 27, 2015 - Jun 16, 2015
Pages
5
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Investigator(s): Shaquenta Y. Perkins and Scott K. Zika