Vitrectomy, Instrument Cutter
The Vitrectomy Instrument Cutter is a precision surgical instrument used during vitreoretinal surgery to mechanically cut and aspirate the vitreous gel and associated membranes from the posterior segment of the eye, allowing removal of vitreous hemorrhage, tractional membranes, or other intraocular pathology. Classified as a Class 2 device under 21 CFR 886.4150 within the Ophthalmic specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MLZ
- Device Class
- FDA class 2
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220030 | Vista Ophthalmics Vitrectomy Probe | May 04, 2022 | Substantially Equivalent | Vista Ophthalmics, LLC |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | Mar 22, 2017 | Substantially Equivalent | Alcon Research, Ltd. |
| K093305 | ENHANCED ULTRA VIT PROBE | Apr 02, 2010 | Substantially Equivalent | Alcon Research, Ltd. |
| K081681 | VITRECTOMY CUTTER AND ACCESSORIES | Oct 08, 2008 | Substantially Equivalent | Advanced Medical Optics, Inc. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.