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The Tracker / September 2025 / K252435

510(k) cleared

Magnetic Surgical System

Levita Magnetics International Corp · Sep 26, 2025 · K252435

FDA cleared the Magnetic Surgical System from Levita Magnetics International Corp on Sep 26, 2025 under K252435, a traditional 510(k). The device falls under product code PNL, Magnetic Surgical System, regulated at 21 CFR 878.4815 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 1, 2025. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Levita Magnetics International Corp in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252435?

K252435 is the FDA 510(k) for Magnetic Surgical System, submitted by Levita Magnetics International Corp. FDA's decision date was Sep 26, 2025, under product code PNL (Magnetic Surgical System).

Who makes the Magnetic Surgical System?

Levita Magnetics International Corp, based in Mountain View, CA, is the applicant of record for K252435.

How long did the K252435 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Sep 26, 2025, 56 days later.

← All decisions in September 2025