LifeStyles® SKYN® Intimate Moments Personal Lubricant— 510(k) K172473

Substantially Equivalent

Sxwell USA, LLC

FDA 510(k) clearance K172473 for LifeStyles® SKYN® Intimate Moments Personal Lubricant, Substantially Equivalent on 2017-12-15. Applicant: Sxwell USA, LLC.

Clearance details

Applicant: Sxwell USA, LLC
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2017-08-15
Decision date: 2017-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iselin, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.