Device class
Class II
Regulation 880.5860
Total clearances
7
2020-07-27 → 2025-11-21
Definition
What is Ophthalmic Syringe
An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye.
Classification details
Medical specialty
General Hospital
Regulation number
880.5860
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Staclear, Inc. |
2 |
1 |
2025-11-21 |
|
Altaviz, LLC
|
1 |
0 |
2025-05-09 |
|
Ocuject, LLC
|
1 |
0 |
2023-09-08 |
|
Hangzhou Sightnovo Medical Technology Co., Ltd. |
1 |
0 |
2025-04-08 |
|
Congruence Medical Solutions, LLC |
1 |
0 |
2024-12-20 |
|
Tribofilm Research, Inc. |
1 |
0 |
2020-07-27 |
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 |
| A4100 |
HCPCS
|
Non-sheet form skin substitute, fda cleared as a device, not otherwise specified (list in addition to primary procedure) ✓ CMS-verified description |
High
|
Syringe, sterile, 1 cc or less, with or without needle; standard code for ophthalmic syringes |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-11-21 |
K251849 |
Staclear, Inc.
|
StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) |
| 2025-05-09 |
K243322 |
Altaviz, LLC
|
Altaviz Intravitreal Syringe |
| 2025-04-08 |
K243027 |
Hangzhou Sightnovo Medical Technology Co., Ltd.
|
Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) |
| 2025-04-03 |
K243936 |
Staclear, Inc.
|
StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) |
| 2024-12-20 |
K243149 |
Congruence Medical Solutions, LLC
|
Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) |
| 2023-09-08 |
K230372 |
Ocuject, LLC
|
VitreJect Syringe |
| 2020-07-27 |
K200242 |
Tribofilm Research, Inc.
|
StaClear Syringe |