510(k) Report

510(k) · Cleared

Cleared

Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control System

K132475510(k) TraditionalCleared May 7, 2014273-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fluoptics · OWN Confocal Optical Imaging

Cleared on May 7, 2014 after a 273-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.

Decided
May 7, 2014
Review
273 days
Class
Class II
Product code
OWN
Recalls
None
Predicates
0

12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2020: 2 descendants cleared2023: 2 descendants cleared2025: 2 descendants cleared2026: 3 descendants cleared2010201520202025
  1. This deviceK132475 Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control…Fluoptics · 2014
  2. Descendant · cites it directly · 10 of its ownK162885 SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2017 · Recalled
  3. Descendant · 2 generations on · 9 of its ownK192174 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
  4. Descendant · 3 generations on · 8 of its ownK200737 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
  5. Descendant · 4 generations on · 5 of its ownK202244 SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
  6. Descendant · 4 generations on · 4 of its ownK230727 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) · 2023

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2015: 12017: 12019: 12020: 22023: 22025: 22026: 3
2015high 3 (2026) · low 0 (2016)2026

Most influential descendants

Showing 5 of 12 · See all
  • K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2017 · cites it directly10descendants
  • K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019 · 2 generations on9descendants
  • K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020 · 3 generations on8descendants
  • K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020 · 4 generations on5descendants
  • K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) · 2023 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K132475Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control SystemFluoptics2014—
+1K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.20171
+2K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)2019—
+3K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)2020—
+4K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)2020—
+4K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
201910
202020
202320
202520
202630
FIG. 1 — Lineage of K132475, 2014–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OWN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OWN device

  1. #1 K231854 1788 4K Camera System with Advanced Imaging…score 24.9 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—PDE Fluorescent Angiographic System
Named without a submission number
—

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.201710
K143474Artemis Hand Held Imaging SystemQuest Medical Imaging20150

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K162885 (Novadaq Technologies, Inc., 2017) has gone furthest, with 10 descendants of its own.

How does its category compare?

All OWN devices

OWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · OWN

3in 2025

2011: 12012: 32013: 22014: 52015: 52016: 22017: 52018: 12019: 72020: 72021: 42022: 42023: 62024: 12025: 32026 (partial year): 7
2007high 7 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWN

196in 2025

2012: 87 days median2014: 208 days median2015: 163 days median2017: 87 days median2019: 81 days median2020: 81 days median2021: 104 days median2022: 41 days median2023: 69 days median2025: 196 days median2026 (partial year): 63 days median
2007high 208 (2014) · low 41 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OWN

1in 2024

2022: 32024: 1
2007high 3 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OWN

197in 2025

2015: 12016: 42017: 122018: 112019: 592020: 1052021: 3122022: 3462023: 1642024: 1652025: 197
2007high 346 (2022) · low 0 (2007)2025

MAUDE reports naming product code OWN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
201238700
20132—00
2014520800
2015516301
20162—04
2017587012
20181—011
2019781059
20207810105
202141040312
20224413346
20236690164
20241—1165
202531960197
20267630—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Fluoptics

3 FDA decisions under this applicant name. See the company

  • K190891Fluobeam LXFluoptics · 2019
  • DEN170092Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control SystemFluoptics · 2018

Recent decisions in OWN

The OWN category page

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https://510kreport.com/device/K132475 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132475: Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132475

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026