Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories— 510(k) K250071
Substantially EquivalentAlma Lasers, Inc.
FDA 510(k) clearance K250071 for Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories, Substantially Equivalent on 2025-09-24. Applicant: Alma Lasers, Inc.. Device class: 2.
Clearance details
- Applicant
- Alma Lasers, Inc.
- Product code
- Code GEX
- 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
- Buffalo Grove, IL, US
Recent devices under product code GEX
view allMore clearances from Alma Lasers, Inc.
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
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.