VitreJect Syringe
FDA 510(k) K230372 · Ocuject, LLC
510(k) numberK230372
Submission
- Device name
- VitreJect Syringe
- Applicant
- Ocuject, LLC
Newport Beach, CA, US - Received
- February 13, 2023
- Decision date
- September 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLY – Ophthalmic Syringe
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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.
Other 510(k)s with product code QLY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)QLY · Traditional | Staclear, Inc. | 11/21/2025SE |
| K243322 | Altaviz Intravitreal SyringeQLY · Traditional | Altaviz, LLC | 05/09/2025SE |
| K243027 | Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27…QLY · Traditional | Hangzhou Sightnovo Medical Technology Co., Ltd. | 04/08/2025SE |
| K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)QLY · Special | Staclear, Inc. | 04/03/2025SE |
| K243149 | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)QLY · Traditional | Congruence Medical Solutions, LLC | 12/20/2024SE |
| K200242 | StaClear SyringeQLY · Traditional | Tribofilm Research, Inc. | 07/27/2020SE |
More from Tribofilm Research, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleQNS · Special | 10/25/2024SE |
| K233343 | SteriCap Safety Needle; VitreJect Safety NeedleFMI · Abbreviated | 11/27/2023SE |
| K230959 | VitreJect® Needle; OcuSafe® NeedleFMI · Traditional | 09/14/2023SE |
| K212544 | MiniLoad SyringeFMF · Special | 10/13/2021SE |
| K212805 | SteriCap Mini Needle and Standard NeedlesFMI · Special | 09/30/2021SE |
| K202432 | MiniLoad SyringeFMF · Traditional | 02/19/2021SE |
| K170768 | Mini NeedleFMI · Traditional | 07/10/2017SE |
Questions and answers
When was VitreJect Syringe cleared by the FDA?
VitreJect Syringe (K230372) received a 510(k) decision of Substantially Equivalent on September 8, 2023, 207 days after the submission was received.
What is the product code of K230372?
The FDA product code is QLY – Ophthalmic Syringe, a Class II (moderate risk) device regulated under 21 CFR 880.5860.