Data / Medical devices / United Kingdom / CYDEN Ltd
CYDEN Ltd: FDA-registered device maker in Swansea, United Kingdom, 8 510(k) clearances
CYDEN Ltd is registered with the FDA (registration 3017400436) in Swansea, United Kingdom. It lists 2 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017400436
- Address
- Unit 1, BA Premises Clarion Close, Enterprise Park, Swansea, United Kingdom, SA6 8QZ
- Owner or operator
- CYDEN LIMITED (9060768)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- May 10, 2019
- Registered through
- 2026
- Brand names listed
- SmoothSkin Bare+, SmoothSkin Pure, SmoothSkin Pure Mini
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US, Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| December 20, 2023 | K233782 | SmoothSkin Pure Adapt (SSG3) | OHT | Substantially Equivalent | Cyden Limited | accessdata.fda.gov |
| April 27, 2023 | K230911 | Braun Skin i.expert | OHT | Substantially Equivalent | Cyden Limited | accessdata.fda.gov |
| January 26, 2022 | K213692 | SmoothSkin Pure Mini | OHT | Substantially Equivalent | Cyden Limited | accessdata.fda.gov |
| July 28, 2021 | K211994 | Braun Silk.expert Mini | OHT | Substantially Equivalent | Cyden Limited | accessdata.fda.gov |
| February 21, 2020 | K200184 | SmoothSkin Pure | OHT | Substantially Equivalent | Cyden Limited | accessdata.fda.gov |
| September 24, 2019 | K192010 | SmoothSkin BARE+ | OHT | Substantially Equivalent | Cyden Limited | accessdata.fda.gov |
| March 18, 2019 | K190366 | BRAUN Silk Expert Pro 3 | OHT | Substantially Equivalent | Cyden Limited | accessdata.fda.gov |
| March 18, 2019 | K190354 | BRAUN Silk.expert Pro 5 | 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 December 20, 2023. 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.