Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4165](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4165) → QCR — Wound Autofluorescence Imaging Device

# QCR · Wound Autofluorescence Imaging Device

_General, Plastic Surgery · 21 CFR 878.4165 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QCR

## Overview

- **Product Code:** QCR
- **Device Name:** Wound Autofluorescence Imaging Device
- **Regulation:** [21 CFR 878.4165](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4165)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN180008](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QCR/DEN180008.md) | MolecuLight i:X | MolecuLight, Inc. | Jul 31, 2018 | DENG |

## Top Applicants

- MolecuLight, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QCR](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QCR)

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