Enhanced Ultra Vit Probe
FDA 510(k) K093305 · Alcon Research, Ltd.
510(k) numberK093305
Submission
- Device name
- Enhanced Ultra Vit Probe
- Applicant
- Alcon Research, Ltd.
Irvine, CA, US - Received
- October 22, 2009
- Decision date
- April 2, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLZ – Vitrectomy, Instrument Cutter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
Other 510(k)s with product code MLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220030 | Vista Ophthalmics Vitrectomy ProbeMLZ · Traditional | Vista Ophthalmics, LLC | 05/04/2022SE |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…MLZ · Special | Alcon Research, Ltd. | 03/22/2017SE |
| K081681 | Vitrectomy Cutter and AccessoriesMLZ · Abbreviated | Advanced Medical Optics, Inc. | 10/08/2008SE |
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| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…MLZ · Special | 03/22/2017SE |
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Questions and answers
When was Enhanced Ultra Vit Probe cleared by the FDA?
Enhanced Ultra Vit Probe (K093305) received a 510(k) decision of Substantially Equivalent on April 2, 2010, 162 days after the submission was received.
What is the product code of K093305?
The FDA product code is MLZ – Vitrectomy, Instrument Cutter, a Class II (moderate risk) device regulated under 21 CFR 886.4150.