Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cyden Limited — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
100 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243362 | SmoothSkin Pure Switch (SSC1) | Cyden Limited | 2024-11-27 | 29 | 0 |
| K240587 | SmoothSkin Pure Unplugged (SSB3) | Cyden Limited | 2024-03-29 | 28 | 0 |
| K233782 | SmoothSkin Pure Adapt (SSG3) | Cyden Limited | 2023-12-20 | 23 | 0 |
| K230911 | Braun Skin i.expert | Cyden Limited | 2023-04-27 | 27 | 0 |
| K213692 | SmoothSkin Pure Mini | Cyden Limited | 2022-01-26 | 64 | 0 |
| K211994 | Braun Silk.expert Mini | Cyden Limited | 2021-07-28 | 30 | 0 |
| K200184 | SmoothSkin Pure | Cyden Limited | 2020-02-21 | 28 | 0 |
| K192010 | SmoothSkin BARE+ | Cyden Limited | 2019-09-24 | 57 | 0 |
| K190366 | BRAUN Silk Expert Pro 3 | Cyden Limited | 2019-03-18 | 31 | 0 |
| K190354 | BRAUN Silk.expert Pro 5 | Cyden Limited | 2019-03-18 | 31 | 0 |
| K170734 | Venus Silk.expert | Cyden Limited | 2017-05-08 | 59 | 0 |
| K163552 | iPulse SmoothSkin BARE Hair Removal Device | Cyden Limited | 2017-03-03 | 74 | 0 |
| K162231 | iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.exper | Cyden Limited | 2016-11-16 | 100 | 0 |
| K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016-04-14 | 8 | 0 |
| K130315 | IPULSE HAIR REMOVAL SYSTEM | Cyden Limited | 2013-07-12 | 154 | 0 |
| K122280 | IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM | Cyden Limited | 2012-10-23 | 85 | 0 |
| K083748 | IPULSE, MODEL: I150 | Cyden Limited | 2009-02-02 | 47 | 0 |
| K080406 | IPULSE, MODEL I400 | Cyden Limited | 2008-03-10 | 25 | 0 |
| K071883 | IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1 | Cyden Limited | 2008-01-23 | 198 | 0 |
| K050165 | MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 | Cyden Limited | 2005-04-19 | 84 | 0 |
| K040156 | IFL PROFESSIONAL SYSTEM, MODEL C100 | Cyden Limited | 2004-03-24 | 61 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda