# K101712: Endovascular Laer Vein System Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Oct 27, 2010 after 131 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
No predicates in its family tree.
29 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ceralas D Diode Laser System (1470nm, 980•`m and 810 urn) with ELVeS Kit: named in the summary without a submission number

## Most influential descendants
- K110080: Radial-Emitting Shaped Fiber Optic Delivery System (2011), 26 descendants of its own
- K120810: Fiberoptic Laser Delivery System (2012), 24 descendants of its own
- K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe (2013), 23 descendants of its own
- K170366: Laser Peripherals, LLC Family of Bare Laser Fibers (2017), 13 descendants of its own
- K220189: LISA Laser Surgical Fibers (2022), 5 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/K101712
Methodology: https://510kreport.com/methodology