# K133006: Neov Diode Laser Family

- Pathway: 510(k) (Traditional)
- Applicant: G.N.S Neolaser, Ltd.
- Decided: Apr 17, 2014 after 204 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: 18 generations back to K943450 (1995). 379 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 393 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 1.
- K120938: The PL-1064 Laser System, Sheaumann Laser, Inc. (2012) Summary page 1.

## Most influential descendants
- K193656: SkyPulse (2020), 11 descendants of its own
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own
- K240179: Medical Diode Laser (Model: L2) (2024), 2 descendants of its own
- K230274: Medical Diode Laser (M2) (2023), 2 descendants of its own
- K241791: Medical Diode Laser Systems (GBOX-6H,  GBOX-10D , GBOX-12D,  GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (2025), 1 descendant of its own

## Indications for use
The neoVi 10 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and liemostasis, or coagulation of soft tissue in conjuriction with endoscopic equipment for medical specialist including: Urology, Thomuic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology. Orthopedics, Podiatry, Arthroscopy, Spinal Surgery. Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Hesd/neck/EI'T and Radiology, Oral Surgery and Dental procedures. The neoV9SO diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemnostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, Genera] Surgery, Ophthalmology, Orthopedics, Podiatry, Artroscopy, Spinal Surgery, Gynecology. Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/nect/ENT and Radiology, Oral Surgery and Dental procedures. The neoVlO064 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscorpic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology. Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery. Neurosurgery, Gastroenterology, Head/tneck/ENT and Radiology, Oral Surgery and Dental procedures- The neoVI 470 diode laser is 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 fbr medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology. General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthioscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Hcad/nck/EU and Radiology, Oral Surgery and Dental. procedures.

Source page: https://510kreport.com/device/K133006
Methodology: https://510kreport.com/methodology