FDA.reportPublic FDA data

AZENA MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30118777213011877721AZENA MEDICAL1N2026-01-011777 Botelho Dr Ste 100 Walnut Creek CA US 94596

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1914011000931905K260765Gemini NOVA 810+980 Soft Tissue LaserNVK2026-03-10
1914011921863170K210350Gemini 2 810+980 Soft Tissue LaserNVK2021-11-18
1914011143489492K192617Gemini 810+980 Soft Tissue LaserGEX2020-02-20
1914011290933625K152032ELUMI 810 + 980 Soft Tissue LaserGEX2015-09-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NVK22026-03-10
GEX22020-02-20

PMN#

GUDID#