Magnetic Surgical System— 510(k) K252435

Name: FDA 510(k) clearance K252435
Creator: U.S. Food and Drug Administration
Published: 2025-09-26

Substantially Equivalent

Levita Magnetics International Corp

FDA 510(k) clearance K252435 for Magnetic Surgical System, Substantially Equivalent on 2025-09-26. Applicant: Levita Magnetics International Corp. Device class: 2.

Clearance details

Applicant: Levita Magnetics International Corp
Product code: Code PNL
Device class: Class 2
Regulation: 21 CFR 878.4815
Advisory panel: General, Plastic Surgery
Date received: 2025-08-01
Decision date: 2025-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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K180894 — Magnetic Surgical System2018-09-19

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