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EPIC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12210191221019EPIC MedTec OEM LLC1Y2026-01-0150 PLANTATION DRIVE Jaffrey NH US 03452
96166833004970277EPIC MedTec OEM Ireland Limited1N2026-01-01ANNACOTTY BUSINESS PARK ANNACOTTY Limerick(County) IE -
30052327733005232773EPIC MedTec OEM Catheter & Wire LLC1Y2026-01-013750 Annapolis Ln N Ste 160 Plymouth MN US 55447
30063653773006365377EPIC SYSTEMS CORPORATION1N2026-01-011979 Milky Way Verona WI US 53593
30185967403018596740EPICA HUMAN HEALTH1Y2026-01-0119810 Asheville Hwy Landrum SC US 29356
30199467613019946761EPICORE BIOSYSTEMS, INC.1N2026-01-01810 Memorial Drive, Suite 100 Cambridge MA US 02139
30157307753015730775EPICARE ACQUISITION, LLC1N2020-04-2511 Princess Road Ste C Lawrenceville NJ US 08648
30166939683016693968Epic Sporting Goods and Apparel, INC.1Y2020-04-251804 Plaza Ave New Hyde Park NY US 11040

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2319101207160271K983977LIGHT AGE EPICARE ALEXANDRITE LASERGEX1999-01-07
2319101566721108K980131ALEX TA2 ERASERGEX1998-02-17
3194391177915439K233230See Factor CT3™OWB2024-06-21
3194391310096816K190856SeeFactorCT3OAS2019-09-20
2319101183560142K113115EPICARE YAGGEX2012-04-03
2319101359075354K091625EPICARE-DUO LASER SYSTEMGEX2009-11-03
2319101435981668K032991LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPXGEX2004-09-14
1700341781846794BK241081
1700341064627626BK200482
1700341663091697BK170032
1700341686931742BK130037
3527261028782340
3531011045320962
3526731049342394
3527261113173922
3531011118804124
3531011125397667
3531011208282686
2951841266972838
3531011280257873
3527261311750889
3531011330109984
1700341352229168
3527261395778539
3527261473437279
3531011544070295
3531011682225487
3527261702179322
3531011713729475
3527261822455530
3526731831327478
3527261894300508
3531011919904525
3527261946995824
3527262019379203
3527262028093252
3527262030762793

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX52012-04-03
OWB12024-06-21
OAS12019-09-20

NDC#

200 records. Showing 1-40. Next

PMN#

46 records. Showing 1-40. Next

Applications#

73 records. Showing 41-73. Previous

GUDID#

80 records. Showing 1-40. Next