FDA 510(k)

Smile Makers Personal Lubricant

K-Nummer: K182100 · 2019-04-25

AntragstellerLfbeauty (Thailand) Limited

Entscheidungsdatum2019-04-25

ProduktcodeNUC

BeratungsausschussOB

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

Zugehörige klinische Studien

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Verwandte Geräte (Code: NUC)

K260117EverslideSpecial Situations, LLC K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.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.

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