Data / Medical devices / China / Cyden Medical Technology (zhejiang) Co., Ltd
Cyden Medical Technology (zhejiang) Co., Ltd: FDA-registered device maker in Jiashan Zhejiang, China, 4 510(k) clearances
Cyden Medical Technology (zhejiang) Co., Ltd is registered with the FDA (registration 3030233762) in Jiashan Zhejiang, China. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 27, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3030233762
- Address
- East of Building C No289, Songhai Road, Huimin District, Jiashan, Zhejiang, China, Jiashan Zhejiang, China, 314100
- Owner or operator
- Cyden Medical Technology (Zhejiang) Co., Ltd (10089142)
- Roles
- Manufacturer
- First device listed
- November 27, 2023
- Registered through
- 2026
- Brand names listed
- SmoothSkin Pure, SmoothSkin Pure Adapt (SSG3), SmoothSkin Pure Mini, SmoothSkin Pure Switch (SSC1)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2024 | K243362 | SmoothSkin Pure Switch (SSC1) | OHT | Substantially Equivalent | Cyden Limited | accessdata.fda.gov |
| December 20, 2023 | K233782 | SmoothSkin Pure Adapt (SSG3) | OHT | Substantially Equivalent | Cyden Limited | accessdata.fda.gov |
| January 26, 2022 | K213692 | SmoothSkin Pure Mini | OHT | Substantially Equivalent | Cyden Limited | accessdata.fda.gov |
| February 21, 2020 | K200184 | SmoothSkin Pure | OHT | Substantially Equivalent | Cyden Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Light Based Over-The-Counter Hair Removal
Updated November 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.