Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1129547606
Device Listing 1129547606
Listing Summary
#
Listing key
1129547606
Premarket submission
K251910
Device
Focal OneĀ®
Applicant
Edap Technomed, Inc.
Product code
PLP
Decision date
2025-11-19
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
94997
9612448
3002806876
EDAP TMS France SA
1
N
2026-01-01
4 rue du Dauphine Vaulx en Velin Rhone FR 69120