ZELTIQ AESTHETICS DERMAL COOLING DEVICE— 510(k) DEN090002
UnknownZeltiq Aesthetics
FDA 510(k) clearance DEN090002 for ZELTIQ AESTHETICS DERMAL COOLING DEVICE, Unknown on 2010-08-24. Applicant: Zeltiq Aesthetics.
Clearance details
- Applicant
- Zeltiq Aesthetics
- Product code
- Code OOK
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Post-NSE
- Location
- Pleasanton, CA, US
Adverse events under product code OOK
product code OOK- Injury
- 10,813
- Total
- 10,813
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.