Device class
—
Regulation —
Total clearances
7
2020-10-21 → 2026-03-13
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Visia Imaging S.R.L. |
2 |
0 |
2023-06-29 |
|
Oculus Optikgeräte GmbH |
2 |
1 |
2026-03-13 |
|
Tomey Corporation
|
1 |
1 |
2025-12-18 |
|
Intelon Optics, Inc. |
1 |
0 |
2024-08-16 |
|
Oculus Optikgerate GmbH |
1 |
0 |
2020-10-21 |
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 |
| 92004 |
CPT
|
— |
Medium
|
Comprehensive eye exam; anterior segment imaging/analysis typically component of full exam |
| 92133 |
CPT
|
— |
Medium
|
Scanning computerized ophthalmic diagnostic imaging (OCT/imaging analysis) |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-03-13 |
K251848 |
Oculus Optikgeräte GmbH
|
Pentacam® Cornea OCT |
| 2025-12-18 |
K252348 |
Tomey Corporation
|
Tomey Optical Biometer OA-2000 (OA-2000) |
| 2024-08-16 |
K223700 |
Intelon Optics, Inc.
|
BOSS |
| 2023-06-29 |
K222933 |
Visia Imaging S.R.L.
|
MYAH |
| 2022-03-01 |
K211868 |
Visia Imaging S.R.L.
|
MYAH |
| 2021-07-14 |
K202989 |
Oculus Optikgeräte GmbH
|
Myopia Master |
| 2020-10-21 |
K201724 |
Oculus Optikgerate GmbH
|
Pentacam AXL Wave |