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
1344188091
Device Listing 1344188091
Listing Summary
#
Listing key
1344188091
Premarket submission
K915117
Device
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
Applicant
Trimedyne, Inc.
Product code
GEX
Decision date
1992-04-02
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
69077
1419951
1419951
TRIMEDYNE, INC.
1
N
2026-01-01
519 N. Smith Avenue, Suite 105 Corona CA US 92878