Class Class II

Focal One® (K251910)

K251910 2025-11-19 Traditional
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Description

Focal One® by Edap Technomed, Inc., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251910
Clearance Date2025-11-19
Clearance TypeTraditional
Product CodePLP
Regulation Number876.4340

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