# K133774: Atoven

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Med USA, Inc.
- Decided: Jun 6, 2014 after 176 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: 12 generations back to K910422 (1992). 260 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110364: Dornier Medilas D Litebeam+ 1470, Dornier Medtech America, Inc. (2011) Summary page 1.

## Most influential descendants
- K160952: Alma Diode Tabletop Laser (2016), 5 descendants of its own
- K241791: Medical Diode Laser Systems (GBOX-6H,  GBOX-10D , GBOX-12D,  GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (2025), 1 descendant of its own
- K234004: Medical diode laser systems (CHARISMA, REGAL) (2025), 1 descendant of its own
- K262426: Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) (2026), 0 descendants of its own
- K251699: The Botticelli (Model: Athena) (2025), 0 descendants of its own

## Indications for use
ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This device intended for treatment of reflux of the saphenous veins of thigh associated with varicose veins and varicosities. Non-Contact mode

Source page: https://510kreport.com/device/K133774
Methodology: https://510kreport.com/methodology