Smile Makers Personal Lubricant— 510(k) K182100

Substantially Equivalent

Lfbeauty (Thailand) Limited

FDA 510(k) clearance K182100 for Smile Makers Personal Lubricant, Substantially Equivalent on 2019-04-25. Applicant: Lfbeauty (Thailand) Limited.

Clearance details

Applicant: Lfbeauty (Thailand) Limited
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2018-08-03
Decision date: 2019-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lamlukka, TH

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.