Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Siken 3D Technology Development Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
150 daysmedian FDA review time
172 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SK | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-23 | 167 | 0 |
| K252142 | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-05 | 150 | 0 |
| K243040 | LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-191 | Shenzhen Siken 3D Technology Development Co., Ltd. | 2024-12-20 | 84 | 0 |
| K232845 | IPL Cooling Hair Removal Device | Shenzhen Siken 3D Technology Development Co., Ltd. | 2023-11-14 | 61 | 0 |
| K222710 | IPL Cooling Hair Removal Device | Shenzhen Siken 3D Technology Development Co., Ltd. | 2022-12-01 | 84 | 0 |
| K163470 | Galvanic Spa, Model: SKB-1405 | Shenzhen Siken 3D Technology Development Co., Ltd. | 2017-06-02 | 172 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda