FDA.reportPublic FDA data

De Novo DEN200028

Device
Lumenis Stellar M22
Contact
shlomit segman
De Novo number
DEN200028
Product code
QIU
Regulation
886.5201
Classification name
intense pulsed light device for managing dry eye
Decision
granted (DENG)
Decision date
2021-02-23
Date received
2020-04-20
Classification advisory
Ophthalmic
Review advisory
Ophthalmic
Type
Direct

Current FDA Classification#

Product code
QIU
Device name
Intense Pulsed Light Device For Managing Dry Eye
Medical specialty
Ophthalmic
Device class
2
Regulation
886.5201
Implant
N
Life sustain/support
N