# DEN170092: Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System

- Pathway: De Novo (Direct)
- Applicant: Fluoptics
- Decided: Nov 2, 2018 after 315 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K191371: MolecuLight i:X (2019), 5 descendants of its own
- K211901: MolecuLightDX (2021), 1 descendant of its own
- K210882: MolecuLight I:X (2021), 1 descendant of its own
- K251678: Swift Ray 1 (2026), 0 descendants of its own
- K242669: SnapshotGLO (KB100) (2025), 0 descendants of its own

## Indications for use
The Fluoptics Fluobeam® Imaging system is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluoptics Fluobeam® Imaging system 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 Fluoptics Fluobeam® Imaging system 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® 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/DEN170092
Methodology: https://510kreport.com/methodology