FDA 510(k)

BONTREE PLUS

K-Number: K251818 · 2026-03-06

Decision Date2026-03-06

Product CodeLYC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BONTREE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Hudens Bio Co., Ltd.. It received FDA 510(k) clearance on 2026-03-06 under 510(k) number K251818. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONTREE PLUS?

BONTREE PLUS is a medical device that received FDA 510(k) clearance on 2026-03-06. The listed applicant is Hudens Bio Co., Ltd.. The 510(k) number is K251818.

When did BONTREE PLUS receive FDA 510(k) clearance?

BONTREE PLUS received FDA 510(k) clearance on 2026-03-06, under 510(k) number K251818.

Who is the listed applicant for BONTREE PLUS?

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

What is the FDA product code for BONTREE PLUS?

The FDA product code for BONTREE PLUS is LYC.

Related Devices (Code: LYC)

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.