FDA product code OUM

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

Ophthalmic·Class 1·21 CFR 886.1050
US regulatory classifications
US Product Code (FDA)
OUM
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 886.1050
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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

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About this record

Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.