FDA.reportPublic FDA data

De Novo DEN040009

Device
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
Contact
diarmaid douglas-hamilton
De Novo number
DEN040009
Product code
MRX
Regulation
884.6200
Classification name
system, assisted reproduction laser
Decision
granted (DENG)
Decision date
2004-11-04
Date received
2004-08-25
Classification advisory
Obstetrics/Gynecology
Review advisory
Obstetrics/Gynecology
Type
Post-NSE

Current FDA Classification#

Product code
MRX
Device name
System, Assisted Reproduction Laser
Medical specialty
Obstetrics/Gynecology
Device class
2
Regulation
884.6200
Implant
N
Life sustain/support
N