Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry— 510(k) K163674

Substantially Equivalent

Neo Cosmetique

FDA 510(k) clearance K163674 for Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry, Substantially Equivalent on 2017-09-22. Applicant: Neo Cosmetique.

Clearance details

Applicant: Neo Cosmetique
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2016-12-27
Decision date: 2017-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Denis, FR

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.