510k
Database
Specialties
Anesthesiology
483
Cardiovascular
1461
Chemistry
339
Dental
1159
Ear, Nose, Throat
215
Gastroenterology & Urology
849
General & Plastic Surgery
1915
General Hospital
1455
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
826
Obstetrics & Gynecology
364
Ophthalmic
242
Orthopedic
2514
Pathology
49
Physical Medicine
443
Radiology
2083
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
313
LLZ
System, Image Processing,...
307
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
263
QIH
Automated Radiological Image...
257
HRS
Plate, Fixation, Bone
247
IYN
System, Imaging, Pulsed Doppler,...
247
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Cooper Lasersonics, Inc.
Medical Device Manufacturer
·
US , Orangeburg , NY
Cooper Lasersonics, Inc. - FDA 510(k) Cleared Devices
54 submissions
·
52 cleared
·
Since 1982
Official Website
54
Total
52
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cooper Lasersonics, Inc.
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 06, 1985
ARGON/KRYPTON LASER SYSTEM 8500
K844209
·
HQB
Ophthalmic
·
98d
Cleared
Jan 03, 1985
MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
K844668
·
HQF
Ophthalmic
·
34d
Cleared
Jun 26, 1984
MODEL 4000 MD-YAG LASER FOR MALIGNANT
K842412
·
HQF
Ophthalmic
·
7d
Cleared
Apr 25, 1984
MONITOR CO2 LASER SURGICAL SYSTEM
K840145
·
HQF
Ophthalmic
·
103d
Filters
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All
54
General & Plastic Surgery
19
Gastroenterology & Urology
12
Ear, Nose, Throat
4
Ophthalmic
4
Obstetrics & Gynecology
4
Radiology
3
Neurology
3
Anesthesiology
3
Cardiovascular
1
Dental
1