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FDA 510(k)

Smile Makers Personal Lubricant

K-Number: K182100 · 2019-04-25

ApplicantLfbeauty (Thailand) Limited
Decision Date2019-04-25
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Smile Makers Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Lfbeauty (Thailand) Limited. It received FDA 510(k) clearance on 2019-04-25 under 510(k) number K182100. 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 Smile Makers Personal Lubricant?

Smile Makers Personal Lubricant is a medical device that received FDA 510(k) clearance on 2019-04-25. The listed applicant is Lfbeauty (Thailand) Limited. The 510(k) number is K182100.

When did Smile Makers Personal Lubricant receive FDA 510(k) clearance?

Smile Makers Personal Lubricant received FDA 510(k) clearance on 2019-04-25, under 510(k) number K182100.

Who is the listed applicant for Smile Makers Personal Lubricant?

The FDA 510(k) record lists Lfbeauty (Thailand) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smile Makers Personal Lubricant?

The FDA product code for Smile Makers Personal Lubricant 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, LLCK261909Plum 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 LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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