# K243683: Deka Bluebeam

- Pathway: 510(k) (Traditional)
- Applicant: El.En S.P.A.
- Decided: Jun 12, 2025 after 195 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 K951034 (1995). 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)
- K192272: Wolf445nm, A.R.C Laser GmbH (2020) Summary page 5.

## Indications for use
The DEKA BlueBeam is a medical device intended for incision, excision, vaporization, ablation, hemostasis and coagulation of body soft tissue.

Source page: https://510kreport.com/device/K243683
Methodology: https://510kreport.com/methodology