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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Parathyroid Autofluorescence Imaging Device
510(k) Number K230898
Device Name FLUOBEAM® LX Red
Applicant
Fluoptics Sas
44 Rue Des Berges
Grenoble,  FR 38000
Applicant Contact Marion Boudet
Correspondent
Getinge
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact Rama Hannineh
Regulation Number878.4550
Classification Product Code
QDG  
Date Received03/31/2023
Decision Date 07/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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