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Sign in to claim this brandCYDEN LIMITED
UK
Last updated May 30, 2026
What CYDEN LIMITED makes
Cyden Limited manufactures home-use devices for intense pulsed light (IPL) hair removal, including standalone units and modifications to professional systems. Their portfolio includes devices like the SmoothSkin series, the SmoothSkin Pure Unplugged (SSB3), and the Venus Silk.expert, designed for at-home use by consumers.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) and UDI registries. Cyden Limited is based in the United Kingdom.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Cyden Limited manufacture?
Cyden Limited specializes in home-use devices focused on intense pulsed light (IPL) hair removal. Their portfolio includes standalone IPL units like the SmoothSkin series and modifications to professional systems, such as the MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100. These devices are designed for consumer use at home, targeting non-invasive hair reduction.
Where is Cyden Limited based?
Cyden Limited is headquartered in the United Kingdom. The company’s location in the UK influences its regulatory compliance, particularly under EU MDR or UKCA markings if applicable, though individual device authorizations depend on their classification and market requirements.
Which regulatory registries list Cyden Limited’s devices?
Cyden Limited’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. These registries track devices that have undergone premarket notification (510(k)) for market clearance in the US and require UDI labeling for traceability and post-market surveillance.
How are Cyden Limited’s devices classified under regulatory frameworks?
Cyden Limited’s devices are classified as Class II under regulatory schemes like the FDA’s classification system. Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Are Cyden Limited’s devices intended for professional use or home use?
Cyden Limited’s devices are explicitly designed for home-use applications. Examples like the SmoothSkin series and SmoothSkin Pure Unplugged (SSB3) are consumer-focused, while modifications like the IFL PROFESSIONAL SYSTEM adaptation (Model C100) may bridge professional and home settings—but the primary market remains at-home IPL hair removal.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- UK
- Address
- —
- Website
- smoothskin.co.uk
- —
- —
- [email protected]
- Phone
- 866.813.4926
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 424832900
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Smoothskin | SmoothSkin Bare+ | FDA UDI | Class II | Active |
| Smoothskin | SmoothSkin Pure Adapt | FDA UDI | Class II | Active |
| Smoothskin | SmoothSkin Pure Fit | FDA UDI | Class II | Active |
| Smoothskin | SmoothSkin GOLD 300k | FDA UDI | Class II | Unknown |
| Smoothskin | SmoothSkin BARE | FDA UDI | Class II | Unknown |
| Smoothskin | SmoothSkin Bare+ | FDA UDI | Class II | Unknown |
| Smoothskin | SmoothSkin Bare Fit | FDA UDI | Class II | Active |
| Smoothskin | SmoothSkin Bare+ | FDA UDI | Class II | Active |
| Smoothskin | SmoothSkin Bare Fit | FDA UDI | Class II | Active |
| Smoothskin | SmoothSkin Bare Fit | FDA UDI | Class II | Active |
| Smoothskin | SmoothSkin Pure Adapt | FDA UDI | Class II | Active |
| Smoothskin | SmoothSkin Pure Mini | FDA UDI | Class II | Active |
| Smoothskin | SmoothSkin Bare+ | FDA UDI | Class II | Unknown |
| Smoothskin | SmoothSkin GOLD 120k | FDA UDI | Class II | Unknown |
| Smoothskin | SmoothSkin Pure | FDA UDI | Class II | Unknown |
| Modification To Ifl Professional System, Model C100 | K050165 | FDA 510(k) | Class II | Active |
| SmoothSkin Pure Unplugged (SSB3) | K240587 | FDA 510(k) | Class II | Active |
| Venus Silk.expert | K170734 | FDA 510(k) | Class II | Active |
| BRAUN Silk.expert Pro 5 | K190354 | FDA 510(k) | Class II | Active |
| Ipulse, Model I400 | K080406 | FDA 510(k) | Class II | Active |
| iPulse SmoothSkin Gold Hair Removal Device | K160968 | FDA 510(k) | Class II | Active |
| Braun Skin i.expert | K230911 | FDA 510(k) | Class II | Active |
| Ifl Professional System, Model C100 | K040156 | FDA 510(k) | Class II | Active |
| Ipulse, Quadra Q4 Platinum Series, Model(s) 1200+series 2, 1300 Series 2, Q4 Series 2 | K071883 | FDA 510(k) | Class II | Active |
| BRAUN Silk Expert Pro 3 | K190366 | FDA 510(k) | Class II | Active |
| Ipulse Smoothskin Hair Removal System | K122280 | FDA 510(k) | Class II | Active |
| iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert | K162231 | FDA 510(k) | Class II | Active |
| Braun Silk.expert Mini | K211994 | FDA 510(k) | Class II | Active |
| Ipulse Hair Removal System | K130315 | FDA 510(k) | Class II | Active |
| SmoothSkin BARE+ | K192010 | FDA 510(k) | Class II | Active |
| SmoothSkin Pure Switch (SSC1) | K243362 | FDA 510(k) | Class II | Active |
| iPulse SmoothSkin BARE Hair Removal Device | K163552 | FDA 510(k) | Class II | Active |
| Ipulse, Model: I150 | K083748 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Cyden Limited SWANSEA, WALES · GB FEI 3004635398