FDA 510(k)

Velacur One (LI-1100)

K-Number: K251728 · 2025-06-26

Decision Date2025-06-26

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Velacur One (LI-1100) is the device name listed in this FDA 510(k) record. The listed applicant is Sonic Incytes Medical Corp. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K251728. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Velacur One (LI-1100)?

Velacur One (LI-1100) is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Sonic Incytes Medical Corp. The 510(k) number is K251728.

When did Velacur One (LI-1100) receive FDA 510(k) clearance?

Velacur One (LI-1100) received FDA 510(k) clearance on 2025-06-26, under 510(k) number K251728.

Who is the listed applicant for Velacur One (LI-1100)?

The FDA 510(k) record lists Sonic Incytes Medical Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velacur One (LI-1100)?

The FDA product code for Velacur One (LI-1100) is IYO.

Related Devices (Code: IYO)

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.