Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3— 510(k) K161198
Substantially EquivalentUsa Laser Biotech, Inc.
FDA 510(k) clearance K161198 for Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3, Substantially Equivalent on 2016-07-26. Applicant: Usa Laser Biotech, Inc..
Clearance details
- Applicant
- Usa Laser Biotech, Inc.
- Product code
- Code ILY
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richmond, VA, 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.