Device class
Class II
Regulation 886.5918
Total clearances
3
2020-07-31 → 2025-10-09
Classification details
Medical specialty
Ophthalmic
Regulation number
886.5918
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Bausch & Lomb, Incorporated
|
1 |
0 |
2020-09-23 |
|
Ophtecs Corporation |
1 |
1 |
2025-10-09 |
|
Dry Eye Innovations, LLC |
1 |
0 |
2020-07-31 |
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 |
| 92340 |
CPT
|
— |
Medium
|
Contact lens care and fitting supplies, but product code indicates supply not fitting service |
| A6345 |
HCPCS
|
— |
Medium
|
Contact lens care solution/supplies HCPCS code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-10-09 |
K251876 |
Ophtecs Corporation
|
cleadew GP hydra one |
| 2020-09-23 |
K200416 |
Bausch & Lomb, Incorporated
|
Boston One Step Liquid Enzymatic Cleaner |
| 2020-07-31 |
K201069 |
Dry Eye Innovations, LLC
|
VibrantVue Scleral Saline |