Wound Autofluorescence Imaging Device

QCR · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4165

Classification

FDA Product Code: QCR
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 878.4165
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown