Lumenis Ltd. - Feb. 15, 2017
Issue Date
Feb 15, 2017
Region
HQ
Category
Device
$117.00
Contact Name
Tzipi Ozer-Armon
Contact Title
CEO
Address 1
6 Hakidma St.
Address 2
Yokneam Ind. Park
City
Yokneam
Zip/Postal Code
20692
Country
Israel
Inspection Range
Jan 30, 2017 - Feb 02, 2017
Pages
9
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): Donna L. Tartaglino Besone and Cynthia L. Gorveatt