Product code QDF

Device name

Parathyroid Autofluorescence Detection Device

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4550

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset