Vista Ophthalmics Vitrectomy Probe
FDA 510(k) clearance K220030 · decided 2022-05-04
Clearance details
- K-number
- K220030
- Device name
- Vista Ophthalmics Vitrectomy Probe
- Applicant
- Vista Ophthalmics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-01-05
- Decision date
- 2022-05-04
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- MLZ
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Katy, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (K170520) | Alcon Research, Ltd. | 2017-03-22 |
| ENHANCED ULTRA VIT PROBE (K093305) | Alcon Research, Ltd. | 2010-04-02 |
| VITRECTOMY CUTTER AND ACCESSORIES (K081681) | Advanced Medical Optics, Inc. | 2008-10-08 |
Recalls involving this device
No recalls on record reference this clearance.