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Digital Therapy Device For Amblyopia

FDA product code QQU · 4 cleared devices

Class 2 Ophthalmic
Regulation
21 CFR 886.5500
Review panel
OP
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-09-29 – 2025-04-09

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.

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