GLAM LED Facial Mask (TB-2386F)— 510(k) K251727

Substantially Equivalent

Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.

FDA 510(k) clearance K251727 for GLAM LED Facial Mask (TB-2386F), Substantially Equivalent on 2025-08-29. Applicant: Touchbeauty Beauty & Health (Shenzhen) Co., Ltd..

Clearance details

Applicant: Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2025-06-05
Decision date: 2025-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.