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Digital Therapy Device For Convergence Insufficiency

Page Type
Product Code
Definition
A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency
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 digital device binocularly displays 3D objects, environments, or other stimuli at various simulated depths or apparent distances from the patient to stimulate and train binocular convergence.
Target Area
Eye
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.1290
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.1290 Fixation device

§ 886.1290 Fixation device.

(a) Identification. A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001]