# K250261: Heager Medical Laser Family (Sabrina/Adolf)

- Pathway: 510(k) (Traditional)
- Applicant: Heager GmbH
- Decided: Aug 26, 2025 after 209 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K943450 (1995). 328 ancestors in all.
No later device cites it as a predicate yet.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212734: Diode laser therapy device, Triangel Rsd Limited (2023) Summary page 6.

## Indications for use
The Heager Medical Laser Family device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K250261
Methodology: https://510kreport.com/methodology