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U.S. Department of Health and Human Services

Product Classification

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Device infrared hematoma detector
Regulation Description Near Infrared (NIR) Brain Hematoma Detector.
Definition To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
Physical State This is a standard infrared handheld laser that is scanned across the scalp. The information is transmitted to a handheld Personal Digital Assistant that displays Optical Density measurements
Technical Method Use of low level infrared laser radiation to detect hemoglobin concentration which relates to presence of a hemotoma.
Target Area To be used on the head. The testing divides the head into 8 sections four on the left side and the corresponding 4 sites on the right side.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeOPT
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Diagnostic and Surgical Devices Branch (DSDB)
Submission Type 510(k)
Regulation Number 882.1935
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