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ELESTA SPA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30150775483015077548ELESTA SPA1N2026-01-01Via Arsiero Salvanti 43 Calenzano Firenze IT 50041

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2279451095818035K261964ECHOLASER X4GEX2026-08-19
2279451276110886K260632LASER THERMAL THERAPY KITGEX2026-03-17
2279451759278380K230460Laser Thermal Therapy KitGEX2023-05-22
2279451375396301K213594ECHOLASER X4GEX2022-05-03
2279451014568492K140470OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBERGEX2014-10-15
2279451008053161K051506MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSYFCG2005-07-27
2279451530741727
2279451675126210

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX52026-08-19
FCG12005-07-27

GUDID#