510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1337
Ear, Nose, Throat
248
Gastroenterology & Urology
972
General & Plastic Surgery
2194
General Hospital
2047
Hematology
126
Immunology
99
Medical Genetics
8
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469
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965
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433
Ophthalmic
275
Orthopedic
2923
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52
Physical Medicine
515
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2442
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Risu Medical Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Fengxi New City Of Xixian New Area
Risu Medical Technology Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Risu Medical Technology Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 23, 2025
Picosecond Laser Device (PF131-BI)
K252345
·
GEX
General & Plastic Surgery
·
87d
Cleared
Jun 27, 2025
Diode laser device (RF3120-BI)
K251329
·
GEX
General & Plastic Surgery
·
58d
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General & Plastic Surgery
2