FDA.reportPublic FDA data

John Hoffer

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96113883002806833John Hoffer1N2026-01-011155 Roberts Blvd Nw KENNESAW GA US 30144
30168815083016881508John Hoffer1N2026-01-011155 roberts blvd suite 100 Barrett Parkway GA US 30144
30403885253040388525John Hoffer1N2026-01-011155 Roberts Blvd Nw KENNESAW, GA US 30144 Kennesaw GA US 30144

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
92851837345952P840008DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT)LNS1984-12-19
92851318835116P000048DORNIER EPOS ULTRANBN2002-01-15
92851093601928K991183DORNIER LASERTRODE FIBERGEX1999-06-09
92851215284415K981718DORNIER MEDILAS HGEX1998-07-17
92851791696427K955019UROTRACT IKQS1995-12-06
2653301056907131K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250FED2025-01-31
3420151090993230K242922Extracorporeal Shock Wave Lithotripter (U200)LNS2025-06-18
2653301018040726K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)FGB2022-10-05
2653301354261033K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ2022-11-09
92851852257577K221903Delta III ProLNS2023-02-22
2653301539063147K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)FGB2022-08-26
92852039072120K213252Dornier ThulioGEX2022-07-27
2653301825764986K201293Ureterorenoscope SystemFGB2020-07-24
2653301288710681K180367Ureterorenoscope SystemFGB2018-07-03
92851226683324K180350Dornier Medilas H Solvo 35 LaserGEX2018-03-07
92852024685228K172084Delta III LithotripterLNS2017-08-08
92851141934075K151485GENESISJAA2015-06-30
92851964394519K151298Gemini XXP-HPLNS2015-07-30
92851918392611K133434GENESIS IIJAA2014-11-26
92852039539912K132672EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTERLNS2013-09-23
92851400277836K130729EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTERLNS2013-05-14
92851106395451K130344DORNIER MEDILAS UROPULSEGEX2013-03-21
92851103328810K122768GENESISJAA2013-01-18
92852021939683K122159DORNIER MEDILAS H30 SOLVOGEX2013-02-01
92851055864527K121656GEMINI LITHOTRIPTERLNS2012-09-24
92851877130858K110364DORNIER MEDILAS D LITEBEAM+ 1470GEX2011-12-07
92851857323918K083500MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSEGEX2009-02-12
92852008594736K080959DORNIER MEDILAS D 30 LASER, MEDILAS D 1064GEX2008-06-27
92851205581698K070536MEDILAS D FAMILY LASERSGEX2007-05-21
92851784786285K061455DORNIER MEDILAS H 20 LASERGEX2006-08-01
92851965499139K021724DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMSGEX2002-08-19
92851909655664K011873DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)LNS2001-08-31
92851353094052K011773DORNIER LITHOTRIPTER 140(DOLI 140)LNS2001-06-22
92851087126183K002929DORNIER COMPACT ALPHA LITHOTRIPTERLNS2001-04-17
92851234523465

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LNS122025-06-18
GEX122022-07-27
FGB42022-10-05
JAA32015-06-30
FED12025-01-31
FAJ12022-11-09
KQS11995-12-06