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
1813875038
Device Listing 1813875038
Listing Summary
#
Listing key
1813875038
Premarket submission
K192045
Device
Ophthalmic Yag Laser System YC-200
Applicant
Nidek Co., Ltd.
Product code
HQF
Decision date
2019-11-15
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
10582
2936921
2936921
NIDEK INCORPORATED
1
Y
2026-01-01
6601 Cascades Court Suite 130 The Colony TX US 75056
10583
8030392
3002807715
NIDEK CO., LTD.
1
N
2026-01-01
34-14 MAEHAMA, HIROISHI-CHO GAMAGORI, AICHI JP 443-0038
10584
3002807715
3002807715
NIDEK CO., LTD. HAMACHO PLANT
1
N
2026-01-01
67-4 HAMA-CHO GAMAGORI, AICHI JP 4430036