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FDA 510(k)

LUBi Water Based Personal Lubricant

K-Number: K203257 · 2020-12-23

ApplicantBoya Biotechnology Co., Ltd.
Decision Date2020-12-23
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LUBi Water Based Personal Lubricant is a medical device manufactured by Boya Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2020-12-23 under approval number K203257. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUBi Water Based Personal Lubricant?

LUBi Water Based Personal Lubricant is a medical device that received FDA 510(k) clearance on 2020-12-23. It is manufactured by Boya Biotechnology Co., Ltd.. The 510(k) number is K203257.

When was LUBi Water Based Personal Lubricant approved by the FDA?

LUBi Water Based Personal Lubricant received FDA 510(k) clearance on 2020-12-23, under approval number K203257.

What company makes LUBi Water Based Personal Lubricant?

LUBi Water Based Personal Lubricant is manufactured by Boya Biotechnology Co., Ltd..

What is the FDA product code for LUBi Water Based Personal Lubricant?

The FDA product code for LUBi Water Based Personal Lubricant is NUC.

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Related PubMed Literature

PMID: 41488933 A narrative review on the environmental impact of medicines: from water analysis and Frontiers in drug safety and regulation (2025)

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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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