Cleared Traditional

K132475 - FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM

K132475 is an FDA 510(k) clearance for FLUOBEAM 800 CLINIC LASER IMAGING DEVIC..., manufactured by Fluoptics. The device is a Class 2 General & Plastic Surgery device with product code OWN cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K132475 · Fluoptics · General & Plastic Surgery device
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May 2014
Decision
273d
Days
Class 2
Risk

K132475 is an FDA 510(k) clearance for the FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Fluoptics (Orinda, US). The FDA issued a Cleared decision on May 7, 2014 after a review of 273 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Fluoptics devices

FDA 510(k) Submission Details - K132475

510(k) Number K132475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2013
Decision Date May 07, 2014
Days to Decision 273 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 115d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWN Device Classification - Class 2, Special Controls

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OWN Confocal Optical Imaging

All 61
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K132475.
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CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
K133466 · Mauna Kea Technologies · Jul 2014
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
K132389 · Daniel & Daniel Consulting · Feb 2014
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
K124031 · Intuitive Surgical, Inc. · Sep 2013
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
K123676 · Mauna Kea Technologies · Apr 2013