Cleared Traditional

K230407 - FloNavi Open Field Fluorescence Imaging...

K230407 is an FDA 510(k) clearance for FloNavi Open Field Fluorescence Imaging..., manufactured by Guangdong Optomedic Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OWN cleared through the Traditional 510(k) pathway after a 152-day FDA review.

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

FDA 510(k) Submission Details - K230407

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
37d slower than avg
Panel avg: 115d · This submission: 152d
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 42
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K230407.
KARL STORZ ICG Imaging System
K232857 · Karl Storz SE & CO. KG · Nov 2023
1788 4K Camera System with Advanced Imaging Modality
K231854 · Stryker · Sep 2023
ActivSight Intraoperative Imaging System
K231344 · Activ Surgical, Inc. · Aug 2023
L12 LED Light Source with AIM
K230754 · Stryker · Apr 2023
SmartSurgN Visualization System
K213943 · Smartsurgn Incorporated · Nov 2022
VS3-Iridium System (VS3-IR)
K223020 · Visionsense, Ltd. · Oct 2022