ENHANCED ULTRA VIT PROBE— 510(k) K093305
Substantially EquivalentAlcon Research, Ltd.
FDA 510(k) clearance K093305 for ENHANCED ULTRA VIT PROBE, Substantially Equivalent on 2010-04-02. Applicant: Alcon Research, Ltd.. Device class: 2.
Clearance details
- Applicant
- Alcon Research, Ltd.
- Product code
- Code MLZ
- Device class
- Class 2
- Regulation
- 21 CFR 886.4150
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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Adverse events under product code MLZ
product code MLZ- Malfunction
- 692
- Total
- 692
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.