Infrared Hematoma Detector

Product Code: OPT

Ophthalmic Medical Laser Products

Definition: To Employ Near-infrared Spectroscopy That Is Intended To Be Used To Evaluate Suspected Brain Hematomas.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 882.1935


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as OPT

3811Infrared Hematoma DetectorNear Infrared (NIR) Brain Hematoma Detector.

Total Product Life Cycle (TPLC) Devices

3811Infrared Hematoma DetectorNear Infrared (NIR) Brain Hematoma Detector.

Pre-market Notifications for OPT

K211617InfrascannerInfrascan, Inc.
K200203InfrascannerInfraScan, Inc.
K120949INFRASCANNERINFRASCAN, INC.

Global Unique Device Identification Database

00861606000302Infrared Hematoma Detector
00861606000326Infrared Hematoma Detector

Maude Adverse Events

ELEVATE PROLAPSE REPAIR SYSTEMAMERICAN MEDICAL SYSTEMS, INC.2013-01-08
ELEVATE PROLAPSE REPAIR SYSTEMAMERICAN MEDICAL SYSTEMS, INC.2013-01-03
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