Braun Aura 7 (6041)— 510(k) K261975
Substantially EquivalentCyDen Limited
FDA 510(k) clearance K261975 for Braun Aura 7 (6041), Substantially Equivalent on 2026-09-30. Applicant: CyDen Limited. Device class: 2.
Summary
The Braun Aura 7 (model 6041) is an over-the-counter hair removal device under OHT, light-based OTC hair removal. The applicant is CyDen Limited, not Braun; the record doesn't describe the relationship between the two companies.
Class II, 21 CFR 878.4810, General and Plastic Surgery panel. CyDen filed it as a Special 510(k).
CyDen is based in Swansea, United Kingdom. Review took 110 days (June 12 to September 30, 2026). The record doesn't explain the length of the clock.
Clearance details
- Applicant
- CyDen Limited
- Product code
- Product code OHT
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Swansea, GB
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More clearances from CyDen Limited
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