ML830 LASER SYSTEM— 510(k) K041364
Substantially EquivalentMicrolight Corporation of America
FDA 510(k) clearance K041364 for ML830 LASER SYSTEM, Substantially Equivalent on 2004-12-13. Applicant: Microlight Corporation of America.
Clearance details
- Applicant
- Microlight Corporation of America
- Product code
- Code ILY
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Adverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
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.