MLZ · Vitrectomy, Instrument Cutter
Ophthalmic · 21 CFR 886.4150 · Class 2
Overview
| Product Code | MLZ |
|---|---|
| Device Name | Vitrectomy, Instrument Cutter |
| Regulation | 21 CFR 886.4150 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.
Classification Rationale
Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220030 | Vista Ophthalmics Vitrectomy Probe | Vista Ophthalmics, LLC | May 4, 2022 | SESE |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | Alcon Research, Ltd. | Mar 22, 2017 | SESE |
| K093305 | ENHANCED ULTRA VIT PROBE | Alcon Research, Ltd. | Apr 2, 2010 | SESE |
| K081681 | VITRECTOMY CUTTER AND ACCESSORIES | Advanced Medical Optics, Inc. | Oct 8, 2008 | SESE |
Top Applicants
- Alcon Research, Ltd. — 2 clearances
- Vista Ophthalmics, LLC — 1 clearance
- Advanced Medical Optics, Inc. — 1 clearance
