510k
Database
Specialties
Anesthesiology
3776
Cardiovascular
10096
Chemistry
8813
Dental
6179
Ear, Nose, Throat
2016
Gastroenterology & Urology
5369
General & Plastic Surgery
8521
General Hospital
6905
Hematology
2056
Immunology
2629
Medical Genetics
16
Microbiology
4952
Neurology
2975
Obstetrics & Gynecology
1899
Ophthalmic
1484
Orthopedic
12533
Pathology
639
Physical Medicine
1638
Radiology
8425
Toxicology
2194
Categories
GEX
Powered Laser Surgical Instrument
1455
GEI
Electrosurgical, Cutting &...
1195
LLZ
System, Image Processing,...
1152
HRS
Plate, Fixation, Bone
947
LNH
System, Nuclear Magnetic...
818
IYN
System, Imaging, Pulsed Doppler,...
795
JWH
Prosthesis, Knee,...
788
ESD
Hearing Aid, Air-conduction,...
740
GCJ
Laparoscope, General & Plastic...
724
DZE
Implant, Endosseous, Root-form
699
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
SI
Fotona D.D.
Medical Device Manufacturer
·
SI , Ljubljana
Fotona D.D. - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 1998
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
Filters
1
2
Cleared
Jun 09, 1999
FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES
K990243
·
GEX
General & Plastic Surgery
·
135d
Cleared
Mar 27, 1998
FOTONA SKINPLUS LASER SYSTEM
K980560
·
GEX
General & Plastic Surgery
·
42d
1
2
Filters
Filter by Specialty
All
27
General & Plastic Surgery
27