Device class
Class II
Regulation 886.5500
Total clearances
5
2021-10-20 → 2025-04-09
Definition
What is Digital Therapy Device For Amblyopia
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.
Classification details
Medical specialty
Ophthalmic
Regulation number
886.5500
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Luminopia, Inc.
|
4 |
0 |
2025-04-09 |
|
Novasight , Ltd. |
1 |
0 |
2022-09-29 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 92065 |
CPT
|
— |
Medium
|
Orthoptic and/or pleoptic training; relates to amblyopia therapy |
| 92082 |
CPT
|
— |
Medium
|
Visual field examination; assessment of visual acuity improvement |
Pulse
Most recent 510(k) clearances