MLZ — Vitrectomy, Instrument Cutter Class II
FDA product code MLZ covers "Vitrectomy, Instrument Cutter", a Class II medical device regulated under 21 CFR 886.4150. Submissions are reviewed by the Ophthalmic panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MLZ
- Device Class
- Class II
- Regulation Number
- 886.4150
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220030 | vista ophthalmics | Vista Ophthalmics Vitrectomy Probe | May 4, 2022 |
| K170520 | alcon research | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitre | March 22, 2017 |
| K093305 | alcon research | ENHANCED ULTRA VIT PROBE | April 2, 2010 |
| K081681 | advanced medical optics | VITRECTOMY CUTTER AND ACCESSORIES | October 8, 2008 |