FDA 510(k)

LubriZenzs

K-Number: K242712 · 2025-06-04

Decision Date2025-06-04

Product CodeNUC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

LubriZenzs is the device name listed in this FDA 510(k) record. The listed applicant is Sk Zen, LLC. It received FDA 510(k) clearance on 2025-06-04 under 510(k) number K242712. 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 LubriZenzs?

LubriZenzs is a medical device that received FDA 510(k) clearance on 2025-06-04. The listed applicant is Sk Zen, LLC. The 510(k) number is K242712.

When did LubriZenzs receive FDA 510(k) clearance?

LubriZenzs received FDA 510(k) clearance on 2025-06-04, under 510(k) number K242712.

Who is the listed applicant for LubriZenzs?

The FDA 510(k) record lists Sk Zen, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LubriZenzs?

The FDA product code for LubriZenzs is NUC.

Related Devices (Code: NUC)

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.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLC K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care Laboratories K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

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.