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U.S. Department of Health and Human Services

Product Classification

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Device adaptometer (biophotometer), software-based data acquistion and stimulus generation
Regulation Description Adaptometer (biophotometer).
Definition Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.
Physical State The device is typically plastic or metal enclosed and desk top-based. In the enclosure are electronic components, including a light source, measurement components. and electronics containing software for data acquisition and stimulus generation.
Technical Method A light source stimulates the retina and the the time required for retinal adaptation (regeneration of the visual purple) is measured. The minimum light threshold is also determined, in this same fashion. Stimulus generation and data acquisition are the only features of the device which are software controlled.
Target Area Retina and ocular structures
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeOUM
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Diagnostic and Surgical Devices Branch (DSDB)
Submission Type 510(k)
Regulation Number 886.1050
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible