Cleared Traditional

K230734 - Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) (FDA 510(k) Clearance)

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

K230734 · Precision Healing, LLC · General & Plastic Surgery device
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Dec 2023
Decision
264d
Days
Class 2
Risk

K230734 is an FDA 510(k) clearance for the Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (3.... Classified as Autofluorescence Imaging Adjunct Tool For Wounds (product code QJF), Class II - Special Controls.

Submitted by Precision Healing, LLC (Fort Worth, US). The FDA issued a Cleared decision on December 5, 2023 after a review of 264 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4550 - 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 Precision Healing, LLC devices

Submission Details

510(k) Number K230734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2023
Decision Date December 05, 2023
Days to Decision 264 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
150d slower than avg
Panel avg: 114d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJF Autofluorescence Imaging Adjunct Tool For Wounds
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4550
Definition An Autofluorescence Detection Device For General Surgery And Dermatological Use Is An Adjunct Tool That Uses Autofluorescence To Detect Tissues Or Structures. This Device Is Not Intended To Provide A Diagnosis.
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 Consultant

Brauer Device Consultant, LLC
Dr. Christine Brauer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.