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U.S. Department of Health and Human Services

Product Classification

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Device camera, ophthalmic, ac-powered, general-use
Regulation Description Ophthalmic camera.
Definition An ophthalmic camera intended to capture and store images of the eye and surrounding area.
Physical State The device is a self-contained unit consisting of hardware (lens, camera sensor), software (capable of storing and basic processing), and a light source. The device is AC-powered.
Technical Method The images may be captured by use with or without mydriatic agents. The device makes use of a series of lenses to capture a clear, high-resolution, non-distorted image of the eye (e.g., retina). Light may be provided by sources such as LED, halogen or incandescent bulb; however, the optical radiation assessment shall not exceed a group 1 determination per ISO 15004-2:2007. The device shall also not incorporate the use of a reference database.
Target Area The target area is the eye (lid, orbit) and ocular tissues (anterior and posterior segment).
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodePJZ
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) Exempt
Regulation Number 886.1120
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of Class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.
    Note: FDA intends to propose exempting these devices from premarket notification pursuant to the criteria at sections 510(l) and 510(m) of the FD&C Act, subject to limitations on exemption criteria found in .9 of the associated classification regulation. Until the publication of a final rule or order exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible