Sutil Rich Personal Lubricant— 510(k) K250629

Substantially Equivalent

Hathor Professional Skincare , Ltd.

FDA 510(k) clearance K250629 for Sutil Rich Personal Lubricant, Substantially Equivalent on 2025-05-02. Applicant: Hathor Professional Skincare , Ltd..

Clearance details

Applicant: Hathor Professional Skincare , Ltd.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2025-03-03
Decision date: 2025-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victoria, CA

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.