510(k) K191421— Sofacia System

Substantially Equivalent

Sofwave Medical, Ltd.

Clearance details

Applicant: Sofwave Medical, Ltd.
Product code: Code OHV
Advisory panel: General, Plastic Surgery
Date received: 2019-05-28
Decision date: 2019-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

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