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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K261977

510(k) cleared

Braun Aura 9 (6042)

Cyden Limited · Sep 25, 2026 · K261977

FDA cleared the Braun Aura 9 (6042) from Cyden Limited on Sep 25, 2026 under K261977, a special 510(k). The device falls under product code OHT, Light Based Over-The-Counter Hair Removal, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 12, 2026. The decision came 105 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Cyden Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261977?

K261977 is the FDA 510(k) for Braun Aura 9 (6042), submitted by Cyden Limited. FDA's decision date was Sep 25, 2026, under product code OHT (Light Based Over-The-Counter Hair Removal).

Who makes the Braun Aura 9 (6042)?

Cyden Limited, based in Swansea, is the applicant of record for K261977.

How long did the K261977 review take?

FDA received the submission on Jun 12, 2026 and issued its decision on Sep 25, 2026, 105 days later.

← All decisions in September 2026