Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72— 510(k) K163329
Substantially EquivalentPulsaderm, LLC
FDA 510(k) clearance K163329 for Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72, Substantially Equivalent on 2017-04-14. Applicant: Pulsaderm, LLC. Device class: 2.
Clearance details
- Applicant
- Pulsaderm, LLC
- Product code
- Code OHS
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Myers, FL, US
Recent devices under product code OHS
view allMore clearances from Pulsaderm, LLC
view allAdverse 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.