OUM

Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation

Product code

OUM

Device name

Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation

Device class

Class 1

21 CFR

21 CFR 886.1050

Medical specialty

Ophthalmic

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.

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