QQU — Digital Therapy Device For Amblyopia Class II
FDA product code QQU covers "Digital Therapy Device For Amblyopia", a Class II medical device regulated under 21 CFR 886.5500. Submissions are reviewed by the Ophthalmic panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QQU
- Device Class
- Class II
- Regulation Number
- 886.5500
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.