Shenzhen Siken 3D Technology Development Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Shenzhen Siken 3D Technology Development Co., Ltd.” (first 2017, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 117 days. Since 2017 the median was 117 days, against 88 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 172 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 84 |
| 2023 | 1 | 61 |
| 2024 | 1 | 84 |
| 2025 | 2 | 158 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Siken 3D Technology Development Co., Ltd. took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 2 | 2 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 2 | 2 |
| OHT | Light Based Over-The-Counter Hair Removal | 2 | 2 |
Review panels
Most recent Shenzhen Siken 3D Technology Development Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | NFO | 2025-12-23 | 167 |
| K252142 | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | OHS | 2025-12-05 | 150 |
| K243040 | LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) | OHS | 2024-12-20 | 84 |
| K232845 | IPL Cooling Hair Removal Device | OHT | 2023-11-14 | 61 |
| K222710 | IPL Cooling Hair Removal Device | OHT | 2022-12-01 | 84 |
| K163470 | Galvanic Spa, Model: SKB-1405 | NFO | 2017-06-02 | 172 |
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Siken 3D Technology Development Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (159 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen Root Innovation Technology Co., Ltd. (13 510(k)s)
- Shenzhen Osto Technology Company Limited (12 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Siken 3D Technology Development Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Shenzhen Siken 3D Technology Development Co., Ltd.” (first 2017, latest 2025), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shenzhen Siken 3D Technology Development Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Siken 3D Technology Development Co., Ltd. is 117 days. Since 2017: 117 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Siken 3D Technology Development Co., Ltd.?
The most frequent FDA product codes under this applicant name are NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 2); OHS (Light Based Over The Counter Wrinkle Reduction, 2); OHT (Light Based Over-The-Counter Hair Removal, 2).
Next steps
- See all 6 Shenzhen Siken 3D Technology Development Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NFO, Shenzhen Siken 3D Technology Development Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.