510(k) K230372
K230372 is an FDA 510(k) premarket notification submitted by Ocuject, LLC for the device "VitreJect Syringe". The FDA issued a decision of Substantially Equivalent on September 8, 2023. The device falls under product code QLY (Ophthalmic Syringe), a Class II device regulated under 21 CFR 880.5860. Ocuject, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2023
- Date Received
- February 13, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ophthalmic Syringe
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
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.