Unicorn+ RF System (4 models)— 510(k) K241832
Substantially EquivalentBoston Aesthetics, Inc.
FDA 510(k) clearance K241832 for Unicorn+ RF System (4 models), Substantially Equivalent on 2025-02-13. Applicant: Boston Aesthetics, Inc.. Device class: 2.
Clearance details
- Device name as filed
- Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
- Applicant
- Boston Aesthetics, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
Recent devices under product code GEI
view allMore clearances from Boston Aesthetics, Inc.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.