# K112299: Endovascular Laser Vein System Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec Medical Devices, Inc.
- Decided: Nov 3, 2011 after 85 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: 1 generation back to K101712 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
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.
- (no number) Ceralas Diode Laser System (1470nm, 980 nm and 810 nm) with ELVeS Kit: named in the summary without a submission number

## Most influential descendants
- K130681: Endovascular Laser Venous System Kit with 2 Ring Radial Emitting Fiber (2014), 0 descendants of its own

## Indications for use
For Endovascular Coagulation of the Greater Saphenous Vein of the Thigh in Patients with Superficial Vein Reflux.

Source page: https://510kreport.com/device/K112299
Methodology: https://510kreport.com/methodology