510k
Database
Specialties
Anesthesiology
2823
Cardiovascular
8648
Chemistry
7330
Dental
4950
Ear, Nose, Throat
1512
Gastroenterology & Urology
4406
General & Plastic Surgery
6976
General Hospital
5669
Hematology
1726
Immunology
2228
Medical Genetics
15
Microbiology
4189
Neurology
2609
Obstetrics & Gynecology
1527
Ophthalmic
1253
Orthopedic
11062
Pathology
580
Physical Medicine
1373
Radiology
7450
Toxicology
1935
Categories
GEX
Powered Laser Surgical Instrument
1044
GEI
Electrosurgical, Cutting &...
1042
LLZ
System, Image Processing,...
959
HRS
Plate, Fixation, Bone
805
LNH
System, Nuclear Magnetic...
797
IYN
System, Imaging, Pulsed Doppler,...
751
JWH
Prosthesis, Knee,...
720
GCJ
Laparoscope, General & Plastic...
646
NKB
Thoracolumbosacral Pedicle Screw...
615
MAX
Intervertebral Fusion Device...
577
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Lumitex, Inc.
Medical Device Manufacturer
·
US , Cleveland , OH
Lumitex, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1991
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lumitex, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 08, 2012
GIRAFFE BLUE SPOT PT LITE
K120820
·
LBI
General Hospital
·
81d
Cleared
Apr 17, 2006
BILISOFT PHOTOTHERAPY SYSTEM
K053568
·
LBI
General Hospital
·
116d
Filters
Filter by Specialty
All
3
General Hospital
2
Ophthalmic
1