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U.S. Department of Health and Human Services

Product Classification

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Device multi-photon imaging
Regulation Description Surgical lamp.
Definition To provide visible illumination of the surgical field or the patient
Physical State Microscopy with multi-photon laser excitation
Technical Method Device emits focused laser beams and scans across the sample to produce an image, including images generated based on multi-photon excitation
Target Area Tissue
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQZN
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4580
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible