# K151890: Medical Diode Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Gigaa Optronics Technology Co., Ltd.
- Decided: Dec 23, 2015 after 166 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: 20 generations back to K943450 (1995). 454 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 458 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.
- K122567: Joule 810/940/980 Multi-Platform System, Sciton, Inc (2013) Summary page 5.
- K100558: Quanta Diode Laser System, Quanta System Spa (2010) Summary page 5.

## Most influential descendants
- K252063: Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (2025), 0 descendants of its own
- K191349: 980nm Diode Laser Therapy Device (2019), 0 descendants of its own
- K173067: LightForce LTS Model 1000, 1500, 2500, and 4000 (2018), 0 descendants of its own

## Indications for use
The "“GBOX-15A/15B" 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). The "VELASII-30A/30B" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (UJrology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology Endovascular coagulation, Oral Surgery and Dental procedures, laser assisted lipolysis. The "VELASII-60A/60B/60C" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue. Such as: Dermatology, Aesthetics, Plastic Surgery, Vascular Surgery, Podiatry, Endovenous Occlusion of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K151890
Methodology: https://510kreport.com/methodology