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133
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568
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163
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313
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68
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287
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515
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372
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67
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56
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0
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232
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165
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61
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49
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1292
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18
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85
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868
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88
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IYN
System, Imaging, Pulsed Doppler,...
150
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Plate, Fixation, Bone
134
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
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Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Luminopia, Inc.
Medical Device Manufacturer
·
US , Cambridge , MA
Luminopia, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
3 cleared
·
Since 2021
4
Total
3
Cleared
1
Denied
FDA 510(k) cleared devices by Luminopia, Inc.
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 09, 2025
Luminopia
K243819
·
QQU
Ophthalmic
·
118d
Cleared
Aug 08, 2024
Luminopia
K233720
·
QQU
Ophthalmic
·
261d
Cleared
Nov 04, 2022
Luminopia One
K221659
·
QQU
Ophthalmic
·
149d
Not Cleared
Oct 20, 2021
Luminopia One
DEN210005
·
QQU
Ophthalmic
·
233d
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4
Ophthalmic
4