LUBi Water Based Personal Lubricant— 510(k) K203257

Substantially Equivalent

Boya Biotechnology Co., Ltd.

FDA 510(k) clearance K203257 for LUBi Water Based Personal Lubricant, Substantially Equivalent on 2020-12-23. Applicant: Boya Biotechnology Co., Ltd..

Clearance details

Applicant: Boya Biotechnology Co., Ltd.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2020-11-04
Decision date: 2020-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

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.