# K230898: FLUOBEAM® LX Red

- Pathway: 510(k) (Special)
- Applicant: Fluoptics Sas
- Decided: Jul 28, 2023 after 119 days
- Product code: QDG (Parathyroid Autofluorescence Imaging Device)
- Device class: 2
- Regulation: 21 CFR 878.4550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K190891 (2019). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190891: Fluobeam LX, Fluoptics (2019) Summary page 4.

## Most influential descendants
- K233564: FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) (2023), 1 descendant of its own
- K250455: FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (2025), 0 descendants of its own

## Indications for use
FLUOBEAM® LX Red is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The FLUOBEAM® LX Red is indicated for use in capturing and viewing fluorescent images for the visual assessment of blood flow in adults as an adjunctive method for the evaluation of tissue perfusion, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries. The FLUOBEAM® LX Red can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue. Use of the FLUOBEAM® LX Red device is intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

Source page: https://510kreport.com/device/K230898
Methodology: https://510kreport.com/methodology