Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)— 510(k) K252142
Substantially EquivalentShenzhen Siken 3D Technology Development Co., Ltd.
FDA 510(k) clearance K252142 for Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209), Substantially Equivalent on 2025-12-05. Applicant: Shenzhen Siken 3D Technology Development Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Siken 3D Technology Development Co., Ltd.
- Product code
- Code OHS
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OHS
view allMore clearances from Shenzhen Siken 3D Technology Development Co., Ltd.
view all- K252146 — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
- K243040 — LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
- K232845 — IPL Cooling Hair Removal Device
- K222710 — IPL Cooling Hair Removal Device
- K163470 — Galvanic Spa, Model: SKB-1405
Adverse events under product code OHS
product code OHS- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.