# K160549: Medical Diode Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Gigaa Optronics Technology Co., Ltd.
- Decided: Apr 7, 2017 after 403 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: 2 generations back to K043046 (2005). 5 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082225: 15W Ceralas D 1470NM Diode Laser, Model D1470, Biolitec, Inc. (2008) Summary page 4.

## Most influential descendants
- K211977: Medical Diode Laser Systems (2021), 3 descendants of its own
- K241930: Veincare (2024), 1 descendant of its own
- K252564: Medical Diode Laser Systems (VeinCure) (2025), 0 descendants of its own
- 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
- K251288: Veincare (2025), 0 descendants of its own

## Indications for use
The “VELASII-15D” is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K160549
Methodology: https://510kreport.com/methodology