QLY — Ophthalmic Syringe Class II
FDA product code QLY covers "Ophthalmic Syringe", a Class II medical device regulated under 21 CFR 880.5860. Submissions are reviewed by the General Hospital panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QLY
- Device Class
- Class II
- Regulation Number
- 880.5860
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251849 | staclear | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250L | November 21, 2025 |
| K243322 | altaviz | Altaviz Intravitreal Syringe | May 9, 2025 |
| K243027 | hangzhou sightnovo medical technology co | Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC I | April 8, 2025 |
| K243936 | staclear | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250L | April 3, 2025 |
| K243149 | congruence medical solutions | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | December 20, 2024 |
| K230372 | ocuject | VitreJect Syringe | September 8, 2023 |
| K200242 | tribofilm research | StaClear Syringe | July 27, 2020 |