Product code OUM— Ophthalmic

ADAPT, MODEL AX-03SN

Classification name: Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
Device class: Class 1
Regulation: 21 CFR 886.1050
Advisory panel: Ophthalmic
Total cleared: 1
First cleared: 2011-02-25
Most recent: 2011-02-25

FDA classification definition

“Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.”
— U.S. Food and Drug Administration, device classification record for product code OUM under 21 CFR 886.1050, via openFDA

Market context for product code OUM

FDA has cleared 1 device under product code OUM, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OUM

Apeliotus Vision Science, Inc.1 clearance

Recent clearances under product code OUM

K100954 — ADAPT, MODEL AX-03SNApeliotus Vision Science, Inc.·2011-02-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.