Fractional CO2 Laser Therapy System (EXFU CO2)— 510(k) K242183
Substantially EquivalentWeifang Mingliang Electronics Co., Ltd.
FDA 510(k) clearance K242183 for Fractional CO2 Laser Therapy System (EXFU CO2), Substantially Equivalent on 2024-10-23. Applicant: Weifang Mingliang Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Weifang Mingliang Electronics Co., Ltd.
- 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
- Weifang, CN
Recent devices under product code GEX
view allMore clearances from Weifang Mingliang Electronics Co., Ltd.
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.