Class Class II

SofWave System (K230019)

K230019 2023-03-14 Traditional
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Description

SofWave System by Sofwave Medical, Ltd. — FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230019
Clearance Date2023-03-14
Clearance TypeTraditional
Product CodeOHV
Regulation Number878.4590

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