510(k) K243322
K243322 is an FDA 510(k) premarket notification submitted by Altaviz, LLC for the device "Altaviz Intravitreal Syringe". The FDA issued a decision of Substantially Equivalent on May 9, 2025. The device falls under product code QLY (Ophthalmic Syringe), a Class II device regulated under 21 CFR 880.5860. Altaviz, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2025
- Date Received
- October 23, 2024
- 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.