LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM— 510(k) K062930
Substantially EquivalentAlcon Research, Ltd.
FDA 510(k) clearance K062930 for LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM, Substantially Equivalent on 2006-11-08. Applicant: Alcon Research, Ltd.. Device class: 1.
Clearance details
- Applicant
- Alcon Research, Ltd.
- Product code
- Code NCF
- Device class
- Class 1
- Regulation
- 21 CFR 886.1760
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Orlando, FL, US
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Adverse events under product code NCF
product code NCF- Injury
- 129
- Total
- 129
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.