WINGDERM ELECTRO-OPTICS LTD.

FDA Regulatory Profile

WINGDERM ELECTRO-OPTICS LTD. appears in FDA public data with 2 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0555-2025, Class II) was initiated on August 23, 2024. Its most recent 510(k) clearance was granted on February 24, 2026.

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0555-2025Class IINon-ablative Fractional Laser Systems, Model: WFB-01August 23, 2024
Z-0556-2025Class IIDiode Laser Hair Removal model: WLA-01August 23, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K252599Diode Laser Therapy Systems (WLA-02)February 24, 2026
K192350Medical Non-Ablative Fractional Laser SystemsApril 30, 2020
K191611Diode Laser Therapy SystemsJuly 31, 2019