510(k) K261975
K261975 is an FDA 510(k) premarket notification submitted by CyDen Limited for the device "Braun Aura 7 (6041)". The FDA issued a decision of Substantially Equivalent on Sep 30, 2026. The device falls under product code OHT (Light Based Over-The-Counter Hair Removal), a Class II device regulated under 21 CFR 878.4810. CyDen Limited has 22 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2026
- Date Received
- Jun 12, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Light Based Over-The-Counter Hair Removal
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
- 510(k)
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.