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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Braun Aura 9 (6042)

FDA 510(k) source

510(k) number
K261977
Applicant
Cyden Limited
Decision date
Sep 25, 2026
Date received
Jun 12, 2026
Decision
Substantially Equivalent
Clearance type
Special
Product code
OHT
Device type
Light Based Over-The-Counter Hair Removal
Device class
Class II
Regulation
21 CFR 878.4810
Advisory committee
General, Plastic Surgery
Statement or summary
Summary
Third party
N
Location
Swansea, GB