# K063396: Velure Family of Diode Lasers and Delivery Device Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Lasering S.R.L.
- Decided: Jan 17, 2007 after 69 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: 14 generations back to K943450 (1995). 175 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042496: Adept Ultralite 532 Laser, Adept Medical Concepts (2004) Summary page 1.
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene, Intermedic Arfran, SA (2006) Summary page 1.

## Most influential descendants
- K100143: Pilot Diode Laser, Model 002-00139 (2010), 20 descendants of its own
- K123443: Precise SHP Diode Laser (2013), 9 descendants of its own
- K102036: Doctor Surgery Diode Lasers Family (2010), 7 descendants of its own
- K122567: Joule 810/940/980 Multi-Platform System (2013), 6 descendants of its own
- K162114: Photon, Photon Plus (2016), 3 descendants of its own

## Indications for use
The Velure Family of Diode Lasers are intended for use in dermatology, hair removal, oral, periodontal and surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue. Velure S5 532nm (Green) Diode Laser Applications: Vascular Lesions Pigmented Lesions Velure S8115, Velure S8/30 and Velure S800 808nm Diode Laser Applications: Vascular Lesions Unwanted Hair Removal Velure S9/15, Velure S9/30 980nm Diode Laser Applications: Surgical Cut and coagulate General Surgery GYN ENT Neuro Urgology Velure S917D and Velure S9/15D 980nm Diode Laser Applications: Oral and Periodontal Surgery Bleaching (tooth whitening)

Source page: https://510kreport.com/device/K063396
Methodology: https://510kreport.com/methodology