510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1699
Chemistry
374
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2213
General Hospital
2062
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
438
Ophthalmic
282
Orthopedic
2988
Pathology
52
Physical Medicine
515
Radiology
2468
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
414
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
284
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Laser Engineering, Inc.
Medical Device Manufacturer
·
US , Milford , MA
Laser Engineering, Inc. - FDA 510(k) Cleared Devices
18 submissions
·
18 cleared
·
Since 1988
18
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Laser Engineering, Inc.
Obstetrics & Gynecology
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 05, 1988
GL-35 COLPOSCOPIC LASER SYSTEM
K875314
·
HHR
Obstetrics & Gynecology
·
220d
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18
General & Plastic Surgery
16
General Hospital
1
Obstetrics & Gynecology
1