# K152722: neoV980 & neoV1470 Diode Lasers

- Pathway: 510(k) (Traditional)
- Applicant: G.N.S Neolaser, Ltd.
- Decided: Dec 8, 2015 after 77 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). 358 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 376 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100558: Quanta Diode Laser System, Quanta System Spa (2010) Summary page 4.
- K112253: Ceralas 147NM Diode Laser System, Biolitec, Inc. (2011) Summary page 4.
- K112324: Ceralas 980NM Diode Laser Family, Biolitec Medical Devices, Inc. (2011) Summary page 4.

## Most influential descendants
- K193656: SkyPulse (2020), 11 descendants of its own
- K240747: Medical Diode Laser (M2-GK) (2024), 4 descendants of its own
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own
- K240644: Medical Diode Laser (S1Pro) (2024), 2 descendants of its own
- K240179: Medical Diode Laser (Model: L2) (2024), 2 descendants of its own

## Indications for use
The neoV980 & neoV1470 Diode Lasers, (and their delivery accessories used to deliver optical energy) 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 specialties including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation, and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K152722
Methodology: https://510kreport.com/methodology