510(k) K220030
K220030 is an FDA 510(k) premarket notification submitted by Vista Ophthalmics, LLC for the device "Vista Ophthalmics Vitrectomy Probe". The FDA issued a decision of Substantially Equivalent on May 4, 2022. The device falls under product code MLZ (Vitrectomy, Instrument Cutter), a Class II device regulated under 21 CFR 886.4150.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2022
- Date Received
- January 5, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vitrectomy, Instrument Cutter
- Device Class
- Class II
- Regulation Number
- 886.4150
- Review Panel
- OP
- Submission Type