# K251327: XERF

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Aug 11, 2025 after 103 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K943450 (1995). 119 ancestors in all.
No later device cites it as a predicate yet.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170758: Thermage FLX System and Accessories, Solta Medical (2017) Summary page 5.

## Recalls of this device
- Sep 4, 2025 · Class II · Z-0146-2026: Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.

## Indications for use
The XERF is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K251327
Methodology: https://510kreport.com/methodology