510k
Database
Specialties
Anesthesiology
204
Cardiovascular
735
Chemistry
187
Dental
463
Ear, Nose, Throat
91
Gastroenterology & Urology
391
General & Plastic Surgery
767
General Hospital
473
Hematology
77
Immunology
63
Medical Genetics
1
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275
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296
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114
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76
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1475
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26
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152
Radiology
1083
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
130
GEX
Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
QIH
Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Strata Skin Sciences, Inc.
Medical Device Manufacturer
·
US , Horsham , PA
Strata Skin Sciences, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Strata Skin Sciences, Inc.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 14, 2020
XTRAC Momentum Excimer Laser System
K193478
·
GEX
General & Plastic Surgery
·
29d
Cleared
Aug 01, 2018
MMD Tip
K181480
·
GEX
General & Plastic Surgery
·
57d
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2
General & Plastic Surgery
2