Sofacia System— 510(k) K191421

Substantially Equivalent

Sofwave Medical, Ltd.

FDA 510(k) clearance K191421 for Sofacia System, Substantially Equivalent on 2019-09-09. Applicant: Sofwave Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Sofwave Medical, Ltd.
Product code: Code OHV
Device class: Class 2
Regulation: 21 CFR 878.4590
Advisory panel: General, Plastic Surgery
Date received: 2019-05-28
Decision date: 2019-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

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