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510k Database
Manufacturers
US
Neauvia North America
Medical Device Manufacturer
·
US , Raliegh , NC
Neauvia North America - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
Recent clearances:
LaserME
,
EpilME
,
Sectum
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Neauvia North America
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 17, 2023
LaserME
K230077
·
GEX
General & Plastic Surgery
·
188d
Cleared
Jun 02, 2022
EpilME
K213261
·
GEX
General & Plastic Surgery
·
245d
Cleared
Jul 30, 2021
Sectum
K202780
·
PBX
General & Plastic Surgery
·
311d
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3
General & Plastic Surgery
3