# K192350: Medical Non-Ablative Fractional Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Wingderm Electro-Optics, Ltd.
- Decided: Apr 30, 2020 after 245 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K910422 (1992). 323 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170060: M22 and ResurFx Systems, Lumenis, Ltd. (2017) Summary page 6.

## Most influential descendants
- K221770: Fiber Laser Treatment System (2022), 1 descendant of its own
- K251031: Fiber Laser Treatment Systems (HS-232,HS-233) (2025), 0 descendants of its own

## Recalls of this device
- Aug 23, 2024 · Class II · Z-0555-2025: 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)

## Indications for use
The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

Source page: https://510kreport.com/device/K192350
Methodology: https://510kreport.com/methodology