QLY
- Product code
- QLY
- Device name
- Ophthalmic Syringe
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5860
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 7 (all years; only the last 3 years are listed here)
FDA classification definition
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.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251849 | 2025-11-21 | Staclear, Inc. | StaClear Syringe (SC250AN); StaClear Syringe (SC250L | |
| K243322 | 2025-05-09 | Altaviz, LLC | Altaviz Intravitreal Syringe | |
| K243027 | 2025-04-08 | Hangzhou Sightnovo Medical Technology | Disposable Aqueous Humor Collector (SnovoDAHC I-50, | |
| K243936 | 2025-04-03 | Staclear, Inc. | StaClear Syringe (SC250AN); StaClear Syringe (SC250L | |
| K243149 | 2024-12-20 | Congruence Medical Solutions, LLC | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 1 |
Official FDA classification page: QLY
Classification and pathway per current FDA publications. Data from openFDA (CC0).