# Braun Aura 7 (6041) (K261975): 510(k) cleared for CyDen Limited

**Predicate Speed & CAPA Advisory Opportunity Score:** 41/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261975 |
| Device | Braun Aura 7 (6041) |
| Applicant | CyDen Limited |
| Specialty / panel | General, Plastic Surgery |
| Product code | OHT |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-06-12 |
| Decision date | 2026-09-30 |
| Review time (days) | 110 |
| Third-party review | No |
| Applicant location | Swansea, GB |

## Why this score
- Fast 110-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 36 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261975). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.