FDA 510(k)

MySegmenter (v2.0.0)

K-Number: K242647 · 2025-04-16

Decision Date2025-04-16

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MySegmenter (v2.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Mysegmenter Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-16 under 510(k) number K242647. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MySegmenter (v2.0.0)?

MySegmenter (v2.0.0) is a medical device that received FDA 510(k) clearance on 2025-04-16. The listed applicant is Mysegmenter Technologies, Inc.. The 510(k) number is K242647.

When did MySegmenter (v2.0.0) receive FDA 510(k) clearance?

MySegmenter (v2.0.0) received FDA 510(k) clearance on 2025-04-16, under 510(k) number K242647.

Who is the listed applicant for MySegmenter (v2.0.0)?

The FDA 510(k) record lists Mysegmenter Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MySegmenter (v2.0.0)?

The FDA product code for MySegmenter (v2.0.0) is LLZ.

Related Devices (Code: LLZ)

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.