Cyden Limited: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Cyden Limited” (first 2004, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 47 days. Since 2017 the median was 30 days, against 88 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 85 |
| 2013 | 1 | 154 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 54 |
| 2017 | 2 | 66 |
| 2018 | 0 | — |
| 2019 | 3 | 31 |
| 2020 | 1 | 28 |
| 2021 | 1 | 30 |
| 2022 | 1 | 64 |
| 2023 | 2 | 25 |
| 2024 | 2 | 28 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cyden Limited took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | 15 | 15 |
| GEX | Powered Laser Surgical Instrument | 6 | 6 |
Review panels
Most recent Cyden Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243362 | SmoothSkin Pure Switch (SSC1) | OHT | 2024-11-27 | 29 |
| K240587 | SmoothSkin Pure Unplugged (SSB3) | OHT | 2024-03-29 | 28 |
| K233782 | SmoothSkin Pure Adapt (SSG3) | OHT | 2023-12-20 | 23 |
| K230911 | Braun Skin i.expert | OHT | 2023-04-27 | 27 |
| K213692 | SmoothSkin Pure Mini | OHT | 2022-01-26 | 64 |
| K211994 | Braun Silk.expert Mini | OHT | 2021-07-28 | 30 |
| K200184 | SmoothSkin Pure | OHT | 2020-02-21 | 28 |
| K192010 | SmoothSkin BARE+ | OHT | 2019-09-24 | 57 |
| K190366 | BRAUN Silk Expert Pro 3 | OHT | 2019-03-18 | 31 |
| K190354 | BRAUN Silk.expert Pro 5 | OHT | 2019-03-18 | 31 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cyden Limited.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cyden Limited?
FDA lists 21 510(k) clearances under the applicant name “Cyden Limited” (first 2004, latest 2024), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cyden Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cyden Limited is 47 days. Since 2017: 30 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cyden Limited?
The most frequent FDA product codes under this applicant name are OHT (Light Based Over-The-Counter Hair Removal, 15); GEX (Powered Laser Surgical Instrument, 6).
Next steps
- See all 21 Cyden Limited clearances with predicates and recalls
- Run predicate analysis for product code OHT, Cyden Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.