510(k) K252142— Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

Substantially Equivalent

Shenzhen Siken 3D Technology Development Co., Ltd.

Clearance details

Applicant: Shenzhen Siken 3D Technology Development Co., Ltd.
Product code: Code OHS
Advisory panel: General, Plastic Surgery
Date received: 2025-07-08
Decision date: 2025-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code OHS

product code OHS

Other: 1
Total: 1

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.