FDA.reportPublic FDA data

LELO USA INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30063172643006317264LELO USA INC.1Y2026-01-015799 Fontanoso Way San Jose CA US 95138

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1282521082560202K243421Lelo Hex Lubricated Natural Rubber Latex CondomHIS2025-03-07
1282521288692840K162511LELO RESPECT HEX Natural Rubber Latex CondomHIS2017-01-13
1282521924719947K160644Lelo Hex Natural Rubber Latex CondomHIS2016-06-30
1282521605934064K150857Banana GoldHIS2015-08-14
1282521939904591K140780KEGEL SMART, KEGELSMART PEARLHIR2014-09-10
1282521950860013
1282521978504642
1282521223037062

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIS72025-03-07
HIR12014-09-10