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Parathyroid Autofluorescence Imaging Device

FDA product code QDG · 5 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4550
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-07-31 – 2025-11-28

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.

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