510k
Database
Specialties
Anesthesiology
456
Cardiovascular
1388
Chemistry
334
Dental
1080
Ear, Nose, Throat
198
Gastroenterology & Urology
822
General & Plastic Surgery
1819
General Hospital
1261
Hematology
124
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
777
Obstetrics & Gynecology
343
Ophthalmic
218
Orthopedic
2436
Pathology
46
Physical Medicine
416
Radiology
2006
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
298
LLZ
System, Image Processing,...
291
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
237
LZA
Polymer Patient Examination Glove
216
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
189
MAX
Intervertebral Fusion Device...
169
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Sharplan Lasers, Inc.
Medical Device Manufacturer
·
US , Allendale , NJ
Sharplan Lasers, Inc. - FDA 510(k) Cleared Devices
78 submissions
·
78 cleared
·
Since 1986
78
Total
78
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sharplan Lasers, Inc.
Obstetrics & Gynecology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 27, 1992
SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR
K913848
·
MGI
Obstetrics & Gynecology
·
213d
Cleared
Apr 21, 1988
CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO
K881010
·
HET
Obstetrics & Gynecology
·
42d
Cleared
Nov 16, 1987
MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
K871579
·
HHR
Obstetrics & Gynecology
·
207d
Filters
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78
General & Plastic Surgery
70
Gastroenterology & Urology
4
Obstetrics & Gynecology
3
Radiology
1