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U.S. Department of Health and Human Services

Product Classification

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Device adaptometer (biophotometer), software-based data acquisition 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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(K) Exempt
Regulation Number 886.1050
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible