WINGDERM ELECTRO-OPTICS LTD.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0555-2025 | Class II | Non-ablative Fractional Laser Systems, Model: WFB-01 | August 23, 2024 |
| Z-0556-2025 | Class II | Diode Laser Hair Removal model: WLA-01 | August 23, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252599 | Diode Laser Therapy Systems (WLA-02) | February 24, 2026 |
| K192350 | Medical Non-Ablative Fractional Laser Systems | April 30, 2020 |
| K191611 | Diode Laser Therapy Systems | July 31, 2019 |