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U.S. Department of Health and Human Services

Product Classification

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Device light based imaging
Regulation Description Surgical lamp.
Definition Emission and collection of light to create an image for medical purposes.
Physical State Device is a light source in a housing and light detectors in a housing that can be aimed at a target tissue
Technical Method Device emits light that is collected from the target tissue and then analyzed to provide information about the target
Target Area Intact human skin
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePSN
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4580
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible