Product code MLZ
- Device name
- Vitrectomy, Instrument Cutter
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4150
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220030 | Vista Ophthalmics Vitrectomy Probe | Vista Ophthalmics, LLC | 2022-05-04 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380650000187 | UNITY | Alcon Laboratories, Inc. | 2025-04-08 |
| 00380657531776 | UNITY | Alcon Laboratories, Inc. | 2025-04-08 |
| 00380657531745 | UNITY | Alcon Laboratories, Inc. | 2025-04-08 |
| 00380657531769 | UNITY | Alcon Laboratories, Inc. | 2024-11-19 |
| 00380657531752 | UNITY | Alcon Laboratories, Inc. | 2024-11-19 |
| 00380657531677 | UNITY | Alcon Laboratories, Inc. | 2024-07-02 |
| 00380650002501 | UNITY | Alcon Laboratories, Inc. | 2024-07-02 |
| 00380657531684 | UNITY | Alcon Laboratories, Inc. | 2024-07-02 |
| 00380657531790 | UNITY | Alcon Laboratories, Inc. | 2024-07-02 |
| 00380657531066 | CONSTELLATION® HYPERVIT® TOTAL PLUS® | Alcon Laboratories, Inc. | 2020-12-11 |
| 00380657531097 | CONSTELLATION® HYPERVIT® TOTAL PLUS® | Alcon Laboratories, Inc. | 2020-12-11 |
| 00380650000965 | CONSTELLATION® HYPERVIT® TOTAL PLUS® | Alcon Laboratories, Inc. | 2020-12-11 |
| 00380650000958 | CONSTELLATION® HYPERVIT® TOTAL PLUS® | Alcon Laboratories, Inc. | 2020-12-11 |
| 00380657515714 | CONSTELLATION ULTRAVIT ENGAUGE | Alcon Laboratories, Inc. | 2020-08-31 |
| 00380657515707 | CONSTELLATION ULTRAVIT ENGAUGE | Alcon Laboratories, Inc. | 2020-08-31 |
| 00380658300227 | CONSTELLATION® HYPERVIT® ENGAUGE® | Alcon Laboratories, Inc. | 2020-01-16 |
| 00380658300234 | CONSTELLATION® HYPERVIT® ENGAUGE® | Alcon Laboratories, Inc. | 2020-01-16 |
| 00380657514380 | CONSTELLATION® ULTRAVIT® ENGAUGE® | Alcon Laboratories, Inc. | 2020-01-16 |
| 00380657509508 | CONSTELLATION® ULTRAVIT® ENGAUGE® | Alcon Laboratories, Inc. | 2020-01-16 |
| 00380657509492 | CONSTELLATION® ULTRAVIT® ENGAUGE® | Alcon Laboratories, Inc. | 2020-01-16 |
| 00380657509485 | CONSTELLATION® ULTRAVIT® ENGAUGE® | Alcon Laboratories, Inc. | 2020-01-16 |
| 00380651284029 | Alcon | Alcon Laboratories, Inc. | 2018-10-26 |
| 00380657524501 | Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT | Alcon Laboratories, Inc. | 2018-07-19 |
| 00380657524518 | Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT | Alcon Laboratories, Inc. | 2018-07-19 |
| 00380657524495 | Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT | Alcon Laboratories, Inc. | 2018-07-19 |
| 00380657524396 | Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT | Alcon Laboratories, Inc. | 2018-07-19 |
| 00380657524389 | Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT | Alcon Laboratories, Inc. | 2018-07-19 |
| 00380657524372 | Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT | Alcon Laboratories, Inc. | 2018-07-19 |
| 00380657524365 | Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT | Alcon Laboratories, Inc. | 2018-07-19 |
| 00380657524358 | Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT | Alcon Laboratories, Inc. | 2018-07-19 |