# K261977: Braun Aura 9 (6042)

- Pathway: 510(k) (Special)
- Applicant: Cyden Limited
- Decided: Sep 25, 2026 after 105 days
- Product code: OHT (Light Based Over-The-Counter Hair Removal)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K950019 (1995). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143003: iPulse Smooth Skin Gold Hair Removal System, Ipulse Limited (2015) Summary page 5.

## Cited in the summary but kept off the family tree
- K243362: SmoothSkin Pure Switch (SSC1), Cyden Limited (2024). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K230910: NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens, Acculens, Inc. (2023). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Braun Aura 9 is intended for the removal of unwanted hair. The Braun Aura 9 is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K261977
Methodology: https://510kreport.com/methodology