510(k) Report

FDA applicant

Cyden Limited

Swansea, GB23 decisions2004–20260 recalls

FDA records 23 decisions for Cyden Limited (Swansea, GB) from 2004 to 2026: 23 510(k) clearances. Most are in product codes OHT (Light Based Over-The-Counter Hair Removal) and GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 31 days from receipt to decision, against 81 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “CyDen Limited”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Cyden Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2008: 22009: 12012: 12013: 12016: 22017: 22019: 32020: 12021: 12022: 12023: 22024: 22026 (partial year): 2
2007high 3 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cyden Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cyden Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OHTLight Based Over-The-Counter Hair Removal17decisions
  • GEXPowered Laser Surgical Instrument6decisions

How long do its 510(k) reviews take?

Since 2016, its 15 510(k)s took a median of 31 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 81 days; 12 of its 15 were faster than that.

Whose devices does it build on?

Its devices cite 20 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 42 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 201627cite it
  • K130315Ipulse Hair Removal SystemCyden Limited · 20137cite it
  • K050165Modification to Ifl Professional System, Model C100Cyden Limited · 20053cite it
  • K213692SmoothSkin Pure MiniCyden Limited · 20221cites it
  • K243362SmoothSkin Pure Switch (SSC1)Cyden Limited · 20241cites it
  • K200184SmoothSkin PureCyden Limited · 20201cites it

What has FDA decided for it lately?

  • K261975Braun Aura 7 (6041)CyDen Limited · 2026
  • K261977Braun Aura 9 (6042)Cyden Limited · 2026
  • K243362SmoothSkin Pure Switch (SSC1)Cyden Limited · 2024
  • K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited · 2024
  • K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited · 2023
  • K230911Braun Skin i.expertCyden Limited · 2023
  • K213692SmoothSkin Pure MiniCyden Limited · 2022
  • K211994Braun Silk.expert MiniCyden Limited · 2021

All 22 as Cyden Limited →The one decision as CyDen Limited →