# K243141: Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Medex Technology Co., Ltd.
- Decided: Dec 26, 2024 after 87 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). 360 ancestors in all.
No later device cites it as a predicate yet.
0 of 361 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082721: Laserpro 810, 940 and 980 Diode Laser Systems, Photo Medex, Inc. (2008) Summary page 5.
- K952754: Sacs, Independent Fiber Coolant System, Surgical Laser Technologies, Inc. (1995) Summary page 5.

## Indications for use
Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only). Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: orthopedics.

Source page: https://510kreport.com/device/K243141
Methodology: https://510kreport.com/methodology