SofWave System— 510(k) K231537

Substantially Equivalent

Sofwave Medical, Ltd.

FDA 510(k) clearance K231537 for SofWave System, Substantially Equivalent on 2023-08-28. 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: 2023-05-30
Decision date: 2023-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Iiit, IL

Download summary PDF View on FDA.gov ↗

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