Autofluorescence Imaging Adjunct Tool For Wounds

QJF · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4550

Classification

FDA Product Code: QJF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4550
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 7

Source

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