Home / Companies / Azena Medical, LLC

Azena Medical, LLC

FDA Regulatory Profile

Azena Medical, LLC appears in FDA public data with 0 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on March 10, 2026.

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

FDA data resources