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FDA 510(k)

BONTREE PLUS

K-Number: K251818 · 2026-03-06

ApplicantHudens Bio Co., Ltd.
Decision Date2026-03-06
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONTREE PLUS is a medical device manufactured by Hudens Bio Co., Ltd.. It received FDA 510(k) clearance on 2026-03-06 under approval 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. It is manufactured by Hudens Bio Co., Ltd.. The 510(k) number is K251818.

When was BONTREE PLUS approved by the FDA?

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

What company makes BONTREE PLUS?

BONTREE PLUS is manufactured by Hudens Bio Co., Ltd..

What is the FDA product code for BONTREE PLUS?

The FDA product code for BONTREE PLUS is LYC.

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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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