Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LifeStyles® SKYN® Intimate Moments Personal Lubricant

K-Number: K172473 · 2017-12-15

ApplicantSxwell USA, LLC
Decision Date2017-12-15
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LifeStyles® SKYN® Intimate Moments Personal Lubricant is a medical device manufactured by Sxwell USA, LLC. It received FDA 510(k) clearance on 2017-12-15 under approval number K172473. 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 LifeStyles® SKYN® Intimate Moments Personal Lubricant?

LifeStyles® SKYN® Intimate Moments Personal Lubricant is a medical device that received FDA 510(k) clearance on 2017-12-15. It is manufactured by Sxwell USA, LLC. The 510(k) number is K172473.

When was LifeStyles® SKYN® Intimate Moments Personal Lubricant approved by the FDA?

LifeStyles® SKYN® Intimate Moments Personal Lubricant received FDA 510(k) clearance on 2017-12-15, under approval number K172473.

What company makes LifeStyles® SKYN® Intimate Moments Personal Lubricant?

LifeStyles® SKYN® Intimate Moments Personal Lubricant is manufactured by Sxwell USA, LLC.

What is the FDA product code for LifeStyles® SKYN® Intimate Moments Personal Lubricant?

The FDA product code for LifeStyles® SKYN® Intimate Moments Personal Lubricant is NUC.

Other Devices by Sxwell USA, LLC

K182438Synthetic Polyisoprene Lubricated Male Condom - 5 senses

Related Devices (Code: NUC)

K161585Mano and Mano Personal LubricantMano and Mano Proprietary Limited K161544Trojan Chain Reaction Personal LubricantChurch & Dwight Co., Inc. K161385Just Like Me Personal LubricantWtfn-Dba Classic Erotica/Holiday Products K152671Pulse Aloe-ahhToaster Labs, Inc. K152628Pulse H20h!Toaster Labs, Inc. K153372Repagyn vaginal suppositoriesFarma-Derma S.R.L.

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.

↑