OPT

Infrared Hematoma Detector

Product code

OPT

Device name

Infrared Hematoma Detector

Device class

Class 2

21 CFR

21 CFR 882.1935

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-12-12.

1 summaries are archived here for direct download.