# Cyden Limited

- Location (FDA's records): Swansea, GB
- FDA decisions: 23 (2004–2026): 23 510(k) clearances
- Names in FDA's records: Cyden Limited (22); CyDen Limited (1)
- Product codes: OHT (17), GEX (6)
- 510(k) review time since 2016: median 31 days, against 81 for FDA's reviews in the same codes and years (12 of 15 faster)
- Predicates its devices cite: 20 (5 its own); citations of its devices by later devices: 42 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ipulse Limited: 6 (https://510kreport.com/company/ipulse)
- Palomar Medical Technologies, Inc.: 2 (https://510kreport.com/company/palomar-medical-technologies)
- Shaser, Inc.: 2 (https://510kreport.com/company/shaser)
- Home Skinovations, Ltd.: 2 (https://510kreport.com/company/home-skinovations)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)
- Radiancy (Israel), Ltd.: 1 (https://510kreport.com/company/radiancy-israel)
- Icn Photonics, Ltd.: 1 (https://510kreport.com/company/icn-photonics)

## Firms that cite its devices most
- Shenzhen Ulike Smart Electronics Co., Ltd.: 7 (https://510kreport.com/company/shenzhen-ulike-smart-electronics)
- Shenzhen Qianyu Technology Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-qianyu-technology)
- Shen Zhen Cosbeauty Co., Ltd.: 2 (https://510kreport.com/company/shen-zhen-cosbeauty)
- Lumenessa Corp: 1 (https://510kreport.com/company/lumenessa)
- Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.: 1 (https://510kreport.com/company/touchbeauty-beauty-health-shenzhen)
- Shenzhen Mywin Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mywin-technology)
- Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-beauty-every-moment-intelligent-electric)
- Cutera, Inc.: 1 (https://510kreport.com/company/cutera)

## Its most-cited devices
- K160968: iPulse SmoothSkin Gold Hair Removal Device (2016), cited by 27
- K130315: Ipulse Hair Removal System (2013), cited by 7
- K050165: Modification to Ifl Professional System, Model C100 (2005), cited by 3
- K213692: SmoothSkin Pure Mini (2022), cited by 1
- K243362: SmoothSkin Pure Switch (SSC1) (2024), cited by 1
- K200184: SmoothSkin Pure (2020), cited by 1

## Recent decisions
- K261975: Braun Aura 7 (6041) (Sep 30, 2026)
- K261977: Braun Aura 9 (6042) (Sep 25, 2026)
- K243362: SmoothSkin Pure Switch (SSC1) (Nov 27, 2024)
- K240587: SmoothSkin Pure Unplugged (SSB3) (Mar 29, 2024)
- K233782: SmoothSkin Pure Adapt (SSG3) (Dec 20, 2023)
- K230911: Braun Skin i.expert (Apr 27, 2023)
- K213692: SmoothSkin Pure Mini (Jan 26, 2022)
- K211994: Braun Silk.expert Mini (Jul 28, 2021)

Source page: https://510kreport.com/company/cyden