510(k) K130225— QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE
Substantially EquivalentSilverbay, LLC, D/B/A Quasar Bio-Tech
Clearance details
- Applicant
- Silverbay, LLC, D/B/A Quasar Bio-Tech
- Product code
- Code OHS
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Coralville, IA, US
Adverse events under product code OHS
product code OHS- Other
- 1
- Total
- 1
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.