Braun Aura 9 (6042)— 510(k) K261977
Substantially EquivalentCyden Limited
FDA 510(k) clearance K261977 for Braun Aura 9 (6042), Substantially Equivalent on 2026-09-25. Applicant: Cyden Limited. Device class: 2.
Summary
The Braun Aura 9 (model 6042) is a light-based over-the-counter hair removal device, product code OHT. The applicant of record is Cyden Limited, not Braun; the record doesn't describe the relationship between the two.
Class II, 21 CFR 878.4810, General and Plastic Surgery panel. It went in as a Special 510(k).
Cyden filed from Swansea, United Kingdom. Review took 105 days (June 12 to September 25, 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
Recent devices under product code OHT
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- K261975 — Braun Aura 7 (6041)
- K262524 — Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
- K261325 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
More clearances from Cyden Limited
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