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U.S. Department of Health and Human Services

Product Classification

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Device parathyroid autofluorescence detection device
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.
Physical State The device has a patient contacting fiber optic probe connected to a console with a coherent excitation light source in the near infrared spectrum. The device is used to capture autofluorescence signals of the target tissues. Imaging contrast agents are not required for autofluorescence detection.
Technical Method The device is a patient contacting device that quantifies the ratio of autofluorescence of parathyroid to thyroid tissue using a coherent excitation light source in the near infrared spectrum.
Target Area Parathyroid glands.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQDF
Premarket Review Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4550
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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