Product Classification

• 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 Code: QZN
• Premarket Review: General Surgery Devices (DHT4A); 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 Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible