# K130681: Endovascular Laser Venous System Kit with 2 Ring Radial Emitting Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec Sia
- Decided: Jan 8, 2014 after 301 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 K101712 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101712: Endovascular Laer Vein System Kit, Biolitec, Inc. (2010) Summary page 1.
- K112299: Endovascular Laser Vein System Kit, Biolitec Medical Devices, Inc. (2011) Summary page 1.
- (no number) ELVeS Kit with Radial Fiber: named in the summary without a submission number
- (no number) Evolve HPD 980-1470nm Multiwavelength: named in the summary without a submission number
- (no number) Ceralas 1470, 980 and 810nm ELVeS kits: named in the summary without a submission number

## Indications for use
Endovascular Coagulation of the Greater Saphenous Vein of the thigh in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K130681
Methodology: https://510kreport.com/methodology