FDA.reportPublic FDA data

Ulthera Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10121871012187Ulthera Inc1N2027-01-016501 Six Forks Rd Raleigh NC US 27615

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1850731149508177K260618Ulthera® SystemOHV2026-05-21
1850731887406603K250418Ulthera System (UC-1 Control Unit PRIME Model 2.1)OHV2025-05-13
1850731479527053K243035Ulthera® SystemOHV2025-02-24
1850731175871584K233996Ulthera System (UC-1 Control Unit PRIME)OHV2024-02-22
1850731575368513K180623Ulthera SystemOHV2018-05-04
1850731883245042K134032ULTHERA SYSTEMOHV2014-06-20
1850732023784269K132028ULTHERA SYSTEMOHV2013-12-11
1850731757110497K122528ULTHERA SYSTEMOHV2012-08-28
1850731634543186K121700ULTHERA SYSTEMOHV2012-10-02
1850731734812242DEN080006ULTHERA SYSTEM, MODEL 8850-0001OHV2009-09-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OHV102026-05-21