QLY
7 FDA 510(k) clearances · Product code
178 daysmedian time to decision
207 days90th percentile
7clearances measured
FDA profile
- Official device name
- Ophthalmic Syringe
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Medical specialty
- General Hospital
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (K251849) | Staclear, Inc. | 2025-11-21 |
| Altaviz Intravitreal Syringe (K243322) | Altaviz, LLC | 2025-05-09 |
| Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) (K243027) | Hangzhou Sightnovo Medical Technology Co., Ltd. | 2025-04-08 |
| StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (K243936) | Staclear, Inc. | 2025-04-03 |
| Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) (K243149) | Congruence Medical Solutions, LLC | 2024-12-20 |
| VitreJect Syringe (K230372) | Ocuject, LLC | 2023-09-08 |
| StaClear Syringe (K200242) | Tribofilm Research, Inc. | 2020-07-27 |
Track QLY automatically
Every clearance here is in the API, with alerts when new ones post.