# K252658: Medical Diode Laser Systems (TR-B)

- Pathway: 510(k) (Traditional)
- Applicant: Baoding Te'Anzhou Electronic Technology Co., Ltd.
- Decided: Nov 28, 2025 after 98 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.
1 later device descends from it; 1 cites it directly.
0 of 330 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.

## Most influential descendants
- K262426: Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) (2026), 0 descendants of its own

## Indications for use
The Medical Diode Laser Systems are 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: Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K252658
Methodology: https://510kreport.com/methodology