Cleared Traditional

K230407 - FloNavi Open Field Fluorescence Imaging System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230407 · Guangdong Optomedic Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
152d
Days
Class 2
Risk

K230407 is an FDA 510(k) clearance for the FloNavi Open Field Fluorescence Imaging System. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Guangdong Optomedic Technologies, Inc. (Foshan, CN). The FDA issued a Cleared decision on July 17, 2023 after a review of 152 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 Guangdong Optomedic Technologies, Inc. devices

Submission Details

510(k) Number K230407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2023
Decision Date July 17, 2023
Days to Decision 152 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 114d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 60
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K230407.
SmartSurgN Visualization System
K242163 · Smartsurgn, Inc. · Apr 2026
KARL STORZ ICG Imaging System with RUBINA® Lens
K254242 · Karl Storz SE & CO. KG · Feb 2026
cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
K251852 · VPIX Medical, Inc. · Feb 2026
IMAGE1 (TC400US)
K253972 · Karl Storz SE & CO. KG · Feb 2026
L12 LED Light Source with AIM
K260108 · Stryker Endoscopy · Feb 2026
VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)
K251336 · Olympus Medical Systems Corp. · Nov 2025