FibroLux
K-Number: K212189 · 2022-09-02
ApplicantMulti Radiance Medical
Decision Date2022-09-02
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
FibroLux is a medical device manufactured by Multi Radiance Medical. It received FDA 510(k) clearance on 2022-09-02 under approval number K212189. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FibroLux?
FibroLux is a medical device that received FDA 510(k) clearance on 2022-09-02. It is manufactured by Multi Radiance Medical. The 510(k) number is K212189.
When was FibroLux approved by the FDA?
FibroLux received FDA 510(k) clearance on 2022-09-02, under approval number K212189.
What company makes FibroLux?
FibroLux is manufactured by Multi Radiance Medical.
What is the FDA product code for FibroLux?
The FDA product code for FibroLux is NHN.
Other Devices by Multi Radiance Medical
Related Devices (Code: NHN)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.