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FDA 510(k)

Coresculpt & Magsculpt

K-Number: K222400 · 2024-02-27

ApplicantK1Med Co., Ltd.
Decision Date2024-02-27
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Coresculpt & Magsculpt is the device name listed in this FDA 510(k) record. The listed applicant is K1Med Co., Ltd.. It received FDA 510(k) clearance on 2024-02-27 under 510(k) number K222400. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Coresculpt & Magsculpt?

Coresculpt & Magsculpt is a medical device that received FDA 510(k) clearance on 2024-02-27. The listed applicant is K1Med Co., Ltd.. The 510(k) number is K222400.

When did Coresculpt & Magsculpt receive FDA 510(k) clearance?

Coresculpt & Magsculpt received FDA 510(k) clearance on 2024-02-27, under 510(k) number K222400.

Who is the listed applicant for Coresculpt & Magsculpt?

The FDA 510(k) record lists K1Med Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coresculpt & Magsculpt?

The FDA product code for Coresculpt & Magsculpt is NGX.

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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