Cyden Limited FDA Record
- Latest inspection NAI · May 24, 2017
- No warning letters matched by name
Cyden Limited has 0 FDA recalls, 1 inspection, 23 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Cyden Limited" is on file.
- Latest inspection
- May 24, 2017 · NAI
- Latest 510(k)
- Sep 30, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 23 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 24, 2017 | Swansea, United Kingdom | Devices | No Action Indicated (NAI) | 3004635398 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004635398 | Swansea, United Kingdom | 1 | May 24, 2017 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| 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 |
| K200184 | SmoothSkin Pure | Feb 21, 2020 |
| K192010 | SmoothSkin BARE+ | Sep 24, 2019 |
| K190366 | BRAUN Silk Expert Pro 3 | Mar 18, 2019 |
| K190354 | BRAUN Silk.expert Pro 5 | Mar 18, 2019 |
| K170734 | Venus Silk.expert | May 8, 2017 |
| K163552 | iPulse SmoothSkin BARE Hair Removal Device | Mar 3, 2017 |
| K162231 | iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert | Nov 16, 2016 |
| K160968 | iPulse SmoothSkin Gold Hair Removal Device | Apr 14, 2016 |
| K130315 | IPULSE HAIR REMOVAL SYSTEM | Jul 12, 2013 |
| K122280 | IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM | Oct 23, 2012 |
| K083748 | IPULSE, MODEL: I150 | Feb 2, 2009 |
| K080406 | IPULSE, MODEL I400 | Mar 10, 2008 |
Cyden Limited and the FDA: common questions
Has Cyden Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Cyden Limited" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Cyden Limited received an FDA Form 483?
FDA has not published a Form 483 for "Cyden Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Cyden Limited?
The most recent FDA inspection on file ended May 24, 2017 at Swansea, United Kingdom and was classified NAI. FDA has 1 inspection of Cyden Limited on file.
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