Z-0555-2025Class II

Non-ablative Fractional Laser Systems, Model: WFB-01

Name: Z-0555-2025 Non-ablative Fractional Laser Systems, Model: WFB-01
Creator: Wingderm Electro-Optics Ltd.
Published: 2024-08-23
License: https://open.fda.gov/license/

Wingderm Electro-Optics Ltd. / initiated 2024-08-23 / Open, Classified / root cause: labeling and UDI

FDA source

WINGDERM ELECTRO-OPTICS LTD. began a recall of Non-ablative Fractional Laser Systems, Model: WFB-01 on 2024-08-23. FDA classified it as Class II and gives the reason as "Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0555-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-23
Posted: 2024-12-05
Recalling firm: Wingderm Electro-Optics Ltd.
Product: Non-ablative Fractional Laser Systems, Model: WFB-01
Product code: ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Reason for recall: Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: The firm sent a notification letter to the relevant distribution on June 6, 2024. Products sold before August 23, 2022, will require a software version upgrade to F1-B-1.1.012 or Higher.
Distribution: Worldwide Distribution
Product codes and lots: F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0555-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0555-2025	Class II	Ongoing	FDA Mandated	2024-12-11	2024-12-05
Z-0556-2025	Class II	Ongoing	FDA Mandated	2024-12-11	2024-12-05

Product code ONG

K192350Class IIMedical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics , Ltd. / cleared 2020-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)