Candela Corp. - Feb. 8, 2017
Issue Date
Mar 08, 2017
Region
Northeast
Category
Device
$117.00
Contact Name
Shlomo Assa
Contact Title
General Manager
Address 1
530 Boston Post Rd.
City
Wayland
State
MA
Zip/Postal Code
01778
Country
United States
Inspection Range
Feb 01, 2017 - Feb 08, 2017
Pages
2
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 has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): James P. Finn and Stephen C. Smith