510k
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Anesthesiology
550
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1722
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385
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1379
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252
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985
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2224
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2088
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127
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101
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474
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441
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283
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3050
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52
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515
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2497
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155
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LZA
Polymer Patient Examination Glove
416
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System, Image Processing,...
401
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Powered Laser Surgical Instrument
363
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359
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Electrosurgical, Cutting &...
310
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System, Imaging, Pulsed Doppler,...
304
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Plate, Fixation, Bone
297
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Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Ivylaser (Beijing) Technology Co.,Ltd
Medical Device Manufacturer
·
CN , Beijing
Ivylaser (Beijing) Technology Co.,Ltd - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ivylaser (Beijing) Technology Co.,Ltd
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 24, 2025
Diode laser system (Night Universe
K250206
·
GEX
General & Plastic Surgery
·
90d
Cleared
Jun 20, 2024
IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
K240611
·
GEX
General & Plastic Surgery
·
107d
Cleared
Jul 03, 2023
IVYLASER Handhold Hair Removal Machine
K230025
·
OHT
General & Plastic Surgery
·
180d
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3
General & Plastic Surgery
3