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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 a medical device manufactured by Lfbeauty (Thailand) Limited. It received FDA 510(k) clearance on 2019-04-25 under approval 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. It is manufactured by Lfbeauty (Thailand) Limited. The 510(k) number is K182100.

When was Smile Makers Personal Lubricant approved by the FDA?

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

What company makes Smile Makers Personal Lubricant?

Smile Makers Personal Lubricant is manufactured by Lfbeauty (Thailand) Limited.

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)

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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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