FDA.reportPublic FDA data

LEADOPTIK INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30429708033042970803LEADOPTIK INC.1N2026-01-012380 Qume Dr Ste A San Jose CA US 95131

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3470711907823957K251730LIA Console (542-7)NQQ2025-12-19
3470711981155219K251402LIA-1 Catheter (542-1)KTI2025-12-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NQQ12025-12-19
KTI12025-12-19