Skip to the page
Get started – free

Data / Medical devices / United Kingdom / Cyden Limited

Cyden Limited: FDA-registered device maker in Swansea, Wales, United Kingdom, 13 510(k) clearances

Cyden Limited is registered with the FDA (registration 3004635398) in Swansea, Wales, United Kingdom. It lists 3 device types. The FDA files 13 510(k) clearances under its listings, the newest dated December 20, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Cyden Limited
FDA registration number
3004635398
Address
Block A, Bay Studios Business Park Fabian Way, Swansea, Wales, United Kingdom, SA1 8QB
Owner or operator
CYDEN LIMITED (9060768)
Roles
Complaint file establishment, Specification developer
First device listed
June 26, 2015
Registered through
2026
Brand names listed
SmoothSkin Bare+, SmoothSkin Pure, SmoothSkin Pure Mini, Smoothskin Bare, Smoothskin Gold

Devices it lists

DeviceProduct codeClassRoleSource
Light Based Over-The-Counter Hair RemovalOHT2Complaint file establishment, Specification developeraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Complaint file establishment, Specification developeraccessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal EffectONF2Complaint file establishment, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 20, 2023K233782SmoothSkin Pure Adapt (SSG3)OHTSubstantially EquivalentCyden Limitedaccessdata.fda.gov
April 27, 2023K230911Braun Skin i.expertOHTSubstantially EquivalentCyden Limitedaccessdata.fda.gov
January 26, 2022K213692SmoothSkin Pure MiniOHTSubstantially EquivalentCyden Limitedaccessdata.fda.gov
July 28, 2021K211994Braun Silk.expert MiniOHTSubstantially EquivalentCyden Limitedaccessdata.fda.gov
February 21, 2020K200184SmoothSkin PureOHTSubstantially EquivalentCyden Limitedaccessdata.fda.gov
September 24, 2019K192010SmoothSkin BARE+OHTSubstantially EquivalentCyden Limitedaccessdata.fda.gov
March 18, 2019K190366BRAUN Silk Expert Pro 3OHTSubstantially EquivalentCyden Limitedaccessdata.fda.gov
March 18, 2019K190354BRAUN Silk.expert Pro 5OHTSubstantially EquivalentCyden Limitedaccessdata.fda.gov
May 8, 2017K170734Venus Silk.expertGEXSubstantially EquivalentCyden Limitedaccessdata.fda.gov
March 3, 2017K163552iPulse SmoothSkin BARE Hair Removal DeviceOHTSubstantially EquivalentCyden Limitedaccessdata.fda.gov
November 16, 2016K162231iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expertOHTSubstantially EquivalentCyden Limitedaccessdata.fda.gov
April 14, 2016K160968iPulse SmoothSkin Gold Hair Removal DeviceOHTSubstantially EquivalentCyden Limitedaccessdata.fda.gov
June 18, 2015K143003iPulse Smooth Skin Gold Hair Removal SystemOHTSubstantially EquivalentIpulse Limitedaccessdata.fda.gov

Compare with other makers

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.