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U.S. Department of Health and Human Services

Product Classification

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Device strabismus detection device
Regulation Description Strabismus detection device.
Definition For the automated detection of misalignment of the visual axes for prescription use only.
Physical State Hardware components are integrated in a housing (e.g., plastic enclosure), which includes the image acquisition optics, the system computer and visual display. User input is limited to only basic device function, such as: “Background” button for background measurements and “Measure” button to perform the measurement of the patient. Device output is conveyed to the operator through LED indicator lights on the surface of the instrument. The device is designed as a non-contact device and is AC powered.
Technical Method Includes a laser diode (Scanning Laser) that emits a beam of polarized laser light onto the retina based on the principle of retinal birefringence scanning (birefringent nerve fibers that surround the fovea change the polarization state of reflected light). A separate laser diode (Rangefinder light) assists the operator to determine the correct distance of the device from the patient. The patient fixates on a fixation target LED. Photo sensors detect the polarization characteristics of reflected laser light from the fovea. A software algorithm is used to determine whether central fixation is present in both eyes (“Not Refer”), or in only one eye (“Refer”).
Target Area The target area is the eye.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodePMW
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.1342
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible