510(k) K220030
- Device
- Vista Ophthalmics Vitrectomy Probe
- Applicant
- Vista Ophthalmics LLC
- 510(k) number
- K220030
- Product code
- MLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-05-04
- Date received
- 2022-01-05
- Regulation
- 886.4150
- Classification name
- Vitrectomy, Instrument Cutter
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Don Knowles
- Address
- 23510 Kingsland Blvd. Suite 200 Katy TX US 77494 77494
FDA Registration Numbers#
- 9681572
- 3003398873
- 3012123033
- 1644019
- 3010208880
- 2935428
- 3010047402
- 3008692839
- 3015456951
- 3012236936
- 2028159
- 3023125126
- 2953359
- 3005941719
- 1649518
- 1319660
- 2523835
- 3033485955
- 2126666
- 1928237
- 3005012805
- 3029973819
- 1650907
- 3010291427
Source Documents#
Other 510(k) Records For Product Code MLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | Alcon Research, Ltd. | 2017-03-22 |
| K093305 | ENHANCED ULTRA VIT PROBE | Alcon Research, Ltd. | 2010-04-02 |
| K081681 | VITRECTOMY CUTTER AND ACCESSORIES | Advanced Medical Optics, Inc. | 2008-10-08 |
Legacy Summary#
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FDA Review#
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