ClearanceBrief
Company ยท CN

Wingderm Electro-Optics , Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (1 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)

Product codes

CodeDeviceRecords
GEXPowered Laser Surgical Instrument3
ONGPowered Laser Surgical Instrument With MicrobeamFractional Output2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 24, 2026K252599Diode Laser Therapy Systems (WLA-02)
Wingderm Electro-Optics , Ltd., CN
GEX
Apr 30, 2020K192350Medical Non-Ablative Fractional Laser Systems
Wingderm Electro-Optics , Ltd., CN
ONG
Jul 31, 2019K191611Diode Laser Therapy Systems
Wingderm Electro-Optics , Ltd., CN
GEX

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 5, 2024WINGDERM ELECTRO-OPTICS LTD.
Diode Laser Hair Removal model: WLA-01
Open, Classified		 GEXK191611
Dec 5, 2024WINGDERM ELECTRO-OPTICS LTD.
Non-ablative Fractional Laser Systems, Model: WFB-01
Open, Classified		 ONGK192350
Get alerts for these product codes