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U.S. Department of Health and Human Services

Product Classification

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Device digital therapy device for amblyopia
Definition A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia.
Physical State Therapeutic algorithms delivered by software. The software needs to work with a visual display, either third-party or integrated hardware. The visual display may be a head-mounted display, tablet, computer screen, etc.
Technical Method The device digitally modifies images or videos such that they are perceived differentially by the amblyopic eye and the fellow eye. The image or video modifications penalize the fellow eye (e.g., by reducing contrast or visibility) and, therefore, encourage the use of the amblyopic eye. The device may apply digital masks on the images or videos for both eyes. The pattern of the mask for one eye is complementary to that for the other eye to encourage binocular fusion.
Target Area Eye
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeQQU
Premarket Review Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5500
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