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Azena Medical, LLC

Country / region:United States (US)

510(k) submissions

2

Latest clearance

2020-02-20

Product codes

1
GEX

Cited as predicate

2
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Product areas

FDA product code distribution

GEX2

510(k) submissions

2 total

K numberDevice nameProduct codeClassDecision date
K192617Gemini 810+980 Soft Tissue LaserGEXClass 22020-02-20
K152032ELUMI 810 + 980 Soft Tissue LaserGEXClass 22015-09-16

Company profile

Canonical name
Azena Medical, LLC
Country
United States(US)

Cited predicates

4

Azena Medical, LLC references 4 predicate/reference devices

Cited as predicate

2

2 submissions cite Azena Medical, LLC as a predicate