FDA product code QLY: Ophthalmic Syringe
QLY is the FDA product code for ophthalmic syringe. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. FDA has cleared 7 510(k) submissions under QLY, 6 in the last five years, from 6 different applicants. The average 510(k) review took 160 days (median 178); 122 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ophthalmic Syringe |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QLY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 178 |
| 2023 | 1 | 207 |
| 2024 | 1 | 81 |
| 2025 | 4 | 163 |
Compare with all 510(k) review times · Search every QLY clearance
Top QLY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Staclear, Inc. | 2 | 2025-11-21 |
| Altaviz, LLC | 1 | 2025-05-09 |
| Hangzhou Sightnovo Medical Technology Co., Ltd. | 1 | 2025-04-08 |
| Congruence Medical Solutions, LLC | 1 | 2024-12-20 |
| Ocuject, LLC | 1 | 2023-09-08 |
1 more applicants have QLY clearances. See the full list in Caduvo.
Most recent QLY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251849 | Staclear, Inc. | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | 2025-11-21 | 158 |
| K243322 | Altaviz, LLC | Altaviz Intravitreal Syringe | 2025-05-09 | 198 |
| 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) | 2025-04-08 | 193 |
| K243936 | Staclear, Inc. | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | 2025-04-03 | 104 |
| K243149 | Congruence Medical Solutions, LLC | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | 2024-12-20 | 81 |
Recalls for QLY devices
openFDA lists no recalls for product code QLY.
Frequently asked questions
What is FDA product code QLY?
QLY is the FDA product code for ophthalmic syringe. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is QLY?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code QLY?
Across 7 cleared submissions the average was 160 days from receipt to decision (median 178).
Which companies have the most QLY clearances?
Staclear, Inc. (2); Altaviz, LLC (1); Hangzhou Sightnovo Medical Technology Co., Ltd. (1); Congruence Medical Solutions, LLC (1); Ocuject, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QLY
- Run a recall and safety report across every QLY manufacturer
- Watch product code QLY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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