# K132475: Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control System

- Pathway: 510(k) (Traditional)
- Applicant: Fluoptics
- Decided: May 7, 2014 after 273 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PDE Fluorescent Angiographic System: named in the summary without a submission number

## Most influential descendants
- K162885: SPY Phi Open Field Handheld Fluorescence Imaging System (2017), 10 descendants of its own
- K192174: SPY Portable Handheld Imaging (SPY-PHI) System (2019), 9 descendants of its own
- K200737: SPY Portable Handheld Imaging (SPY-PHI) System (2020), 8 descendants of its own
- K202244: SPY-PHI System with SPY-PHI Fluorescence Assessment Software (2020), 5 descendants of its own
- K230727: SPY Portable Handheld Imaging (SPY-PHI) System (2023), 4 descendants of its own

## Indications for use
As an imaging system used 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, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.

Source page: https://510kreport.com/device/K132475
Methodology: https://510kreport.com/methodology