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Azena Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260765Gemini NOVA 810+980 Soft Tissue LaserMarch 10, 2026
K210350Gemini 2 810+980 Soft Tissue LaserNovember 18, 2021
K192617Gemini 810+980 Soft Tissue LaserFebruary 20, 2020
K152032ELUMI 810 + 980 Soft Tissue LaserSeptember 16, 2015