BeShape One Device— 510(k) K231628

Substantially Equivalent

Beshape Technologies , Ltd.

FDA 510(k) clearance K231628 for BeShape One Device, Substantially Equivalent on 2023-09-29. Applicant: Beshape Technologies , Ltd.. Device class: 2.

Clearance details

Applicant: Beshape Technologies , Ltd.
Product code: Code OHV
Device class: Class 2
Regulation: 21 CFR 878.4590
Advisory panel: General, Plastic Surgery
Date received: 2023-06-05
Decision date: 2023-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar-Saba, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.